Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical function and intended use of standard laparoscopic instruments, with no mention of AI or ML capabilities.

Therapeutic

No.
The device is described as surgical instruments (scissors, forceps, graspers, etc.) used in laparoscopic procedures for grasping, cutting, clamping, biopsy, and/or cauterization of tissue, which are interventional actions rather than therapeutic in the sense of treating a disease or condition through non-interventional means.

Diagnostic

No

Explanation: The device is described as laparoscopic instruments intended for grasping, cutting, clamping, biopsy, and/or cauterization of tissue, and explicitly states their functional use is manipulative (e.g., scissors, forceps, graspers). It does not mention any function for identifying or analyzing medical conditions or diseases. While it can perform a "biopsy," the instrument itself is for taking the sample, not analyzing or diagnosing from it.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical, hand-held laparoscopic instruments with mechanical components (tips, jaws, linkage mechanism, handle) and mentions hardware-related performance studies (electrical, EMC, cleaning, sterilization, biocompatibility, mechanical testing). There is no mention of software as the primary or sole component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the instruments are for "grasping, cutting, clamping, biopsy, and/or cauterization of tissue" during laparoscopic procedures. These are surgical interventions performed directly on the patient's internal tissue.
Device Description: The description details instruments with tips and jaws designed for physical manipulation of tissue within the body.
Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide diagnostic information. IVDs are specifically designed for testing samples in vitro (in glass or in a lab setting).

The device is a surgical instrument used in vivo (within the living body) for therapeutic and diagnostic (biopsy) purposes, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Endoplus Hand held Laparosopic instruments are intended for grasping, cutting, clamping, biopsy, and/or cauterization of tissue. The devices are used in conjunction with a laparoscopic procedures. Instruments should be used only by personnel completely familiar with their operation. Using an instrument improperly for a task which it was not intended may result in a damaged or broken instrument.

Product codes (comma separated list FDA assigned to the subject device)

GEI

Device Description

The devices are commonly named hand held laparoscopic instruments. Specifically, each instrument has a different tip or jaw to define the functional use, such as scissors, forceps, graspers, biopsy, dissectors or needle holders. The devices are designed to be used through a portal, the opening maintained by an introducer or cannula which allows for insertion and removal of the device without damage to surrounding soft tissue. The devices have a linkage mechanism connecting the working tips, or jaws to a handle. This allows the surgeon to cut, dissect, grasp, clamp, cauterize, palpate, or retract at the operating site in conjunction with a laparoscope.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

For use by physician in the operating room.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Safety Testing:
Electrical and EMC Testing:

IEC 60601-1: 2012 3rd edition Medical electrical equipment—Part 1: . General requirements for basic safety and essential performance
. IEC 60601-1-2 Edition 3: 2007-03, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
IEC 60601-2-2: 2009 Medical electrical equipment Part 2-2: Particular ● requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

Cleaning and Sterilization Tests:

Manual cleaning validation study and Laparoscopic Instrument Rack TOC analysis (AAMI TIR30:2011)
Manual cleaning validation study and Laparoscopic Instrument Rack Protein ● analysis
. Steam Pre-vacuum Efficacy Validation Study
Steam Sterilization Validation Study
Shelf Life Protocol

Biocompatibility Tests (in accordance with ISO 10993-1, for externally communicating devices in contact with circulating blood for less than 24 hours):

· Cytotoxicity
· Sensitization
Irritation
Systemic toxicity
Intracutaneous
Hemolysis

Performance Testing:

PLTW Comparative Ex-Vivo Thermal Tissue Testing Validation Study
. Electrical Safety Validation Report (Electrical Safety Testing)
Scissors Performance Testing
Expected Life Testing

Key Results: The Endoplus Hand held Laparoscopic instruments have a similar Indications for Use and identical technological characteristics to the predicate device. Biocompatibility and performance testing has been performed to verify safe use and effective use.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K062072

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.

(a)
Identification. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract human figures, possibly representing individuals or families, with flowing lines suggesting movement or connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 23, 2015

Endoplus % E.J. Smith Consultant Smith Associates 1468 Harwell Avenue Crofton. Marvland 21114

Re: K151567

Trade/Device Name: Endoplus Hand-held Laparoscopic Instruments Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: June 8, 2015 Received: June 10, 2015

Dear E.J. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

1

Page 2 - E.J. Smith

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Binita S. Ashar -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K151567

Device Name

Endopus Hand Held Laparoscopic Instruments

Indications for Use (Describe)

Endoplus Hand held Laparosopic instruments are intended for grasping, cutting, clamping, biopsy, and/or cauterization of tissue. The devices are used in conjunction with a laparoscopic procedures. Instruments should be used only by personnel completely familiar with their operation. Using an instrument improperly for a task which it was not intended may result in a damaged or broken instrument.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

Page 1 of 2

SC Publishing Services (301) 443-6740

3

510(k) Summary

SPONSOR
Company Name:	ENDOPLUS
Company Address	750 Tower Road, Suite A
Mundelelin, IL 60060
Telephone:	800.236.5972
Contact Person:	Matthew Gudeman
Summary Preparation Date:	December 23, 2015
DEVICE NAME
Trade Name:	ENDOPLUS Hand held Laparoscopic
Instruments Common/Usual Name:	Hand-held Surgical Instruments
Classification Name:	Electrosurgical, cutting & coagulation & accessories
Regulation Number:	21 CFR 878.4400
Product Code:	GEI
Device Class:	Class II

PREDICATE DEVICE

Legally Marketed Equivalent Device

Manufacturer	Brand Name	510(k) Number
Pajunk GmbH Medizintechnologie	Pajunks disposable inserts for
handled instrument and HF
Electrodes	K062072

DEVICE DESCRIPTION

The devices are commonly named hand held laparoscopic instruments. Specifically, each instrument has a different tip or jaw to define the functional use, such as scissors, forceps, graspers, biopsy, dissectors or needle holders. The devices are designed to be used through a portal, the opening maintained by an introducer or cannula which allows for insertion and removal of the device without damage to surrounding soft tissue. The devices have a linkage mechanism connecting the working tips, or jaws to a handle. This allows the surgeon to cut, dissect, grasp, clamp, cauterize, palpate, or retract at the operating site in conjunction with a laparoscope.

4

DEVICE INDICATIONS FOR USE

Hand held Laparoscopic instruments are intended for grasping, cutting, dissecting, retracting, clamping, biopsy, and/or cauterization of tissue. The devices are used in conjunction with a laparoscope during laparoscopic procedures. Instruments should be used only by personnel completely familiar with their operation.

Parameters	Endoplus	Pajunk GmbH	Comments
510(k) Number		K062072
Indications for Use	Endoplus Hand held
Laparoscopic
instruments are
intended for
grasping, cutting,
dissecting,
retracting, clamping,
biopsy, and/or
cauterization of
tissue. The devices
are used in
conjunction with a
laparoscope during
laparoscopic
procedures.
Instruments should be
used only by personnel
completely familiar
with their operation.
Using an instrument
improperly for a task
which it was not
intended may result in
a damaged or broken
instrument.	Pajunks disposable
inserts are instruments
insulated for optional
monopolar coagulation
which enable a surgeon
to grasp, manipulate,
dissect, retrieve,
biopsy, cut or
coagulate internal
tissue or organs while
performing
laparoscopic
procedures.	Similar
User Environment	For use by physician
in the operating
room	For use by physician
in the operating
room	Identical
Monopolar	Yes	Yes	Identical
Length	20cm to 50cm	33cm to 45cm	Similar
Minimum Cannula
Size	5.5cm	5.5cm	Identical
Handle Design	Pistol Grip	Pistol Grip	Identical
Shaft Rotation	Yes	Yes	Identical
Shaft Flexibility	Rigid	Rigid	Identical
Parameters	Endoplus	Pajunk GmbH	Comments
Shaft Diameter	5mm	5mm	Identical
Articulating
Component	Does not articulate	Does not articulate	Identical
Actuation
Mechanism	Handle Operation
causes opening and
closing of end
effector	Handle Operation
causes opening and
closing of end
effector	Identical
Flush Port	Yes	No	Different
Insertion through
trocar	Yes	Yes	Identical
Form inserted into
trocar	Jaws closed	Jaws closed	Identical
Reusable/Disposable	Reusable Handle,
Shaft and Insert	Disposable Insert
Reusable Handle and
Shaft Assembly	Different

SUBSTANTIALLY EQUIVALENCE COMPARISON TABLE

5

DIFFERENCES

. Endoplus includes a flush port feature for introducing cleaning fluids during the cleaning and providing a means for steam to enter during the sterilization process.
. Endoplus's inserts are reusable and Pajunk's inserts are disposable.

COMPARISON OF TECHNICAL CHARACTERISTICS

The Endoplus Hand held Laparoscopic instruments has a similar Indications for Use and identical technological characteristics to the predicate device. Any material differences were addressed by biocompatibility, performance and electrical testing found below:

PERFORMANCE DATA

Safety Testing

Electrical and EMC Testing

Endoplus performed the following electrical tests:

IEC 60601-1: 2012 3rd edition Medical electrical equipment—Part 1: . General requirements for basic safety and essential performance
. IEC 60601-1-2 Edition 3: 2007-03, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.

6

IEC 60601-2-2: 2009 Medical electrical equipment Part 2-2: Particular ● requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

Cleaning and Sterilization

The Reusable Hand-held Laparoscopic instruments are evaluated based on the following tests:

Manual cleaning validation study and Laparoscopic Instrument Rack TOC analysis (AAMI TIR30:2011)
Manual cleaning validation study and Laparoscopic Instrument Rack Protein ● analysis
. Steam Pre-vacuum Efficacy Validation Study
Steam Sterilization Validation Study
Shelf Life Protocol

Biocompatibility

In accordance with ISO 10993-1, Hand-held Laparoscopic instruments are categorized as externally communicating devices in contact with circulating blood for less than 24 hours. The following tests are recommended by ISO 10993-1:

· Cytotoxicity
· Sensitization
Irritation
Systemic toxicity
Intracutaneous
Hemolysis

Performance Testing:

PLTW Comparative Ex-Vivo Thermal Tissue Testing Validation Study
. Electrical Safety Validation Report (Electrical Safety Testing)
Scissors Performance Testing
Expected Life Testing

CONCLUSION

The Endoplus Hand held Laparoscopic instruments has a similar Indications for Use and identical technological characteristics to the predicate device. Biocompatibility and

7

performance testing has been performed to verify safe use and effective use. Endoplus concludes that Endoplus Hand held Laparoscopic instruments are substantially equivalent to the predicate device and introduces no new issues of safety and effectiveness.

| Modular
Item #'s | diameter
(mm) | Type |---------------------|-- | 5293 | 5 Serrations |
| 5293L | 5 Serrations |
| 5294 | 5 | 5294L | 5 | 5295 | 5 Forsep w/ cup |
| 5295L | 5 Forsep w/ cup |
| 5296 | 5 | 5296L | 5 | 5297 | 5 | 5297L | 5 | 5300 | 5 | 5300L | 5 | 5301 | 5 | 5301L | 5 | 5302 | 5 | 5302L | 5 | 5303 | 5 | 5303L | 5 | Modular
Item #'s | diameter
(mm) | Type | 5304 | 5 | 5304L | 5 | 5305 | 5 | 5305L | 5 | 5306 | 5 | 5306L | 5 | 5307 | 5 Forcep |
| 5307L | 5 Forcep |
| 5308 | 5 | 5308L | 5 | 5309 | 5 | 5309L | 5 | 5310 | 5 | 5310L | 5 | 5311 | 5 | 5311L | 5 | 5312 | 5 | 5312L | 5 | 5313 | 5 | 5313L | 5 | 5314 | 5 | 5314L | 5 | 5315 | 5 | Modular
Item #'s | diameter
(mm) | Type | 5315L | 5 | 5316 | 5 | 5316L | 5 | 5317 | 5 | 5317L | 5 | 5318 | 5 | 5318L | 5 | 5319 | 5 | 5319L | 5 | 5320 | 5 | 5320L | 5 | 5321 | 5 | 5321L | 5 | 5322 | 5 | 5322L | 5 | 5323 | 5 | 5323L | 5 | 5324 | 5 | 5324L | 5 | 5325 | 5 | 5325L | 5 | 5326 | 5 | 5326L | 5 | 5327 | 5 | Modular
Item #'s | diameter
(mm) | Type | 5327L | 5 | 5328 | 5 | 5328L | 5 | 5329 | 5 | 5329L | 5 | 5330 | 5 | 5330L | 5 | 5331 | 5 | 5331L | 5 | 5332 | 5 | 5332L | 5 | 5333 | 5 | 5333L | 5 | 5334 | 5 | 5334L | 5 | 5335 | 5 | 5335L | 5 | 5336 | 5 | 5336L | 5 | 5337 | 5 | 5337L | 5 | 5338 | 5 | 5338L | 5 | 5339 | 5 | Modular
Item #'s | diameter
(mm) | Type | 5339L | 5 | 5340 | 5 | 5340L | 5 | 5341 | 5 | 5341L | 5 | 5342 | 5 | 5342L | 5 | 5343 | 5 | 5343L | 5 | 5344 | 5 | 5344L | 5 | 5345 | 5 | 5345L | 5 | 5346 | 5 | 5346L | 5 | 5347 | 5 | 5347L | 5 | 5348 | 5 | 5348L | 5 | 5349 | 5 | 5349L | 5 | 5350 | 5 | 5350L | 5 | 5351 | 5 | Modular
Item #'s | diameter
(mm) | Type | 5351L | 5 | 5352 | 5 | 5352L | 5 | 5353 | 5 | 5353L | 5 | 5354 | 5 | 5354L | 5 | 5355 | 5 | 5355L | 5 | 5356 | 5 | 5356L | 5 | 5357 | 5 | 5357L | 5 | 5358 | 5 | 5358L | 5 | 5359 | 5 | 5359L | 5 | 5360 | 5 | 5360L | 5 | 5361 | 5 | 5361L | 5 | 5362 | 5 | 5362L | 5 | 5363 | 5 | Modular
Item #'s | diameter
(mm) | Type | 5363L | 5 | 5364 | 5 | 5364L | 5 | 5365 | 5 | 5365L | 5 | 5366 | 5 | 5366L | 5 | 5367 | 5 | 5367L | 5 | 5368 | 5 | 5368L | 5 | 5369 | 5 | 5369L | 5 | 5370 | 5 | 5370L | 5 | 5371 | 5 | 5371L | 5 | 5372 | 5 | 5372L | 5 | 5373 | 5 | 5373L | 5 | 5374 | 5 | 5374L | 5 | 5375 | 5 | Modular
Item #'s | diameter
(mm) | Type | 5375L | 5 | 5376 | 5 | 5376L | 5 | 5377 | 5 | 5377L | 5 | 5378 | 5 | 5378L | 5 | 5379 | 5 | 5379L | 5 | 5380 | 5 | 5380L | 5 | 5381 | 5 | 5381L | 5 | 5382 | 5 | 5382L | 5 | 5383 | 5 bottom) |
| 5383L | 5 bottom) |
| 5384 | 5 | 5384L | 5 | 5385 | 5 | 5385L | 5 | 5386 | 5 | 5386L | 5 | Modular
Item #'s | diameter
(mm) | Type | 5387 | 5 | 5387L | 5 | 5388 | 5 | 5388L | 5 | 5389 | 5 | 5389L | 5 | 5390 | 5 | 5390L | 5 | 5391 | 5 | 5391L | 5 | 5392 | 5 | 5392L | 5 | 5393 | 5 | 5393L | 5 | 5394 | 5 | 5394L | 5 | 5395 | 5 | 5395L | 5 | SLRVA | 5 | SLRVL | 5 | 5SLR | 5 | 5SLRL | 5 | 5MRR | 5 Ratchet on Demand |
| 5MRRL | 5 | Modular
Item #'s | diameter
(mm) | Type | | | 5MROT | 5 Rotation, NO Ratchet |
| 5MROTL | 5 Rotation, NO Ratchet | | Length | Descriptions |
----------------|-------------|-----------|-----------------------------------------------------------|
| insert | standard | Delicate Maryland with Cross
| insert | bariatric | Delicate Maryland with Cross
| insert | standard | Johan Forcep |
| insert | bariatric | Johan Forcep |
| insert | standard | Medium Dolphin Nose Dissecting
| insert | bariatric | Medium Dolphin Nose Dissecting
| insert | standard | Medium Fenestrated Bowel Grasper |
| insert | bariatric | Medium Fenestrated Bowel Grasper |
| insert | standard | Strevy Grasper |
| insert | bariatric | Strevy Grasper |
| insert | standard | Allis forcep |
| insert | bariatric | Allis forcep |
| insert | standard | Long Allis Forcep |
| insert | bariatric | Long Allis Forcep |
| insert | standard | Traumatic Grasper 2x3 Teeth |
| insert | bariatric | Traumatic Grasper 2x3 Teeth |
| insert | standard | Endo Allis Forcep |
| insert | bariatric | Endo Allis Forcep |
| Length | Descriptions |
| insert | standard | Glassman Forcep |
| insert | bariatric | Glassman Forcep |
| insert | standard | Pennington Forcep |
| insert | bariatric | Pennington Forcep |
| insert | standard | Strong Fenestrated Grasping Forcep |
| insert | bariatric | Strong Fenestrated Grasping Forcep |
| insert | standard | McKernan Tri Grasping Fenestrated
| insert | bariatric | McKernan Tri Grasping Fenestrated
| insert | standard | Alligator Forcep |
| insert | bariatric | Alligator Forcep |
| insert | standard | Pointed Dissector w/ cup |
| insert | bariatric | Pointed Dissector w/ cup |
| insert | standard | Round Tip Allis Grasping Forcep |
| insert | bariatric | Round Tip Allis Grasping Forcep |
| insert | standard | Curved Dissecting Forcep |
| insert | bariatric | Curved Dissecting Forcep |
| insert | standard | Short Curved Dissecting Forcep |
| insert | bariatric | Short Curved Dissecting Forcep |
| insert | standard | Mixter Dissector |
| insert | bariatric | Mixter Dissector |
| insert | standard | Duckbill Dissector |
| insert | bariatric | Duckbill Dissector |
| insert | standard | Straight Tapered Dissector |
| Length | Descriptions |
| insert | bariatric | Straight Tapered Dissector |
| insert | standard | Straight Mini Dissector |
| insert | bariatric | Straight Mini Dissector |
| insert | standard | Mini Right Angle Dissector |
| insert | bariatric | Mini Right Angle Dissector |
| insert | standard | Atraumatic Tube Forcep |
| insert | bariatric | Atraumatic Tube Forcep |
| insert | standard | Delicate Cone Dissector |
| insert | bariatric | Delicate Cone Dissector |
| insert | standard | Micro Dolphin Dissecting Forcep |
| insert | bariatric | Micro Dolphin Dissecting Forcep |
| insert | standard | Claw Forcep 2x3 Teeth |
| insert | bariatric | Claw Forcep 2x3 Teeth |
| insert | standard | Biopsy Forcep w/ Two Teeth |
| insert | bariatric | Biopsy Forcep w/ Two Teeth |
| insert | standard | Dorsey Fenestrated Grasper |
| insert | bariatric | Dorsey Fenestrated Grasper |
| insert | standard | Endo Babcock Forcep |
| insert | bariatric | Endo Babcock Forcep |
| insert | standard | Debakey Tissue Forcep |
| insert | bariatric | Debakey Tissue Forcep |
| insert | standard | Extracting Forcep Reverse Teeth |
| insert | bariatric | Extracting Forcep Reverse Teeth |
| insert | standard | Grasping Forcep |
| Length | Descriptions |
| insert | bariatric | Grasping Forcep |
| insert | standard | Fenestrated Grasping Forcep |
| insert | bariatric | Fenestrated Grasping Forcep |
| insert | standard | Micro Dissecting Forcep |
| insert | bariatric | Micro Dissecting Forcep |
| insert | standard | Babcock Grasping Forcep |
| insert | bariatric | Babcock Grasping Forcep |
| insert | standard | Dolphin Nose Dissecting Forsep w/ cup |
| insert | bariatric | Dolphin Nose Dissecting Forsep w/ cup |
| insert | standard | Cobra Jaw Grasping Forcep |
| insert | bariatric | Cobra Jaw Grasping Forcep |
| insert | standard | Atraumatic Grasper |
| insert | bariatric | Atraumatic Grasper |
| insert | standard | Wave Jaw Grasping Forcep |
| insert | bariatric | Wave Jaw Grasping Forcep |
| insert | standard | Paddle Babcock |
| insert | bariatric | Paddle Babcock |
| insert | standard | Tri-Grasper |
| insert | bariatric | Tri-Grasper |
| insert | standard | Long Grasping Forcep |
| insert | bariatric | Long Grasping Forcep |
| insert | standard | Maxi Fenestrated Grasping Forcep |
| insert | bariatric | Maxi Fenestrated Grasping Forcep |
| insert | standard | Retrograde Grasping Forcep |
| Length | Descriptions |
| insert | bariatric | Retrograde Grasping Forcep |
| insert | standard | Kocher Grasping Forcep |
| insert | bariatric | Kocher Grasping Forcep |
| insert | standard | Curved Maryland Dissector |
| insert | bariatric | Curved Maryland Dissector |
| insert | standard | Dolphin Nose Grasping Forcep |
| insert | bariatric | Dolphin Nose Grasping Forcep |
| insert | standard | Micro Dolphin Dissector w/ Cup |
| insert | bariatric | Micro Dolphin Dissector w/ Cup |
| insert | standard | Oviduct Atraumatic Forcep |
| insert | bariatric | Oviduct Atraumatic Forcep |
| insert | standard | Traumatic Grasper, 2x3 Teeth S/A |
| insert | bariatric | Traumatic Grasper, 2x3 Teeth S/A |
| insert | standard | Atraumatic Grasper S/A |
| insert | bariatric | Atraumatic Grasper S/A |
| insert | standard | Grasping Forcep w/ cup |
| insert | bariatric | Grasping Forcep w/ cup |
| insert | standard | Ripple Claw Forcep |
| insert | bariatric | Ripple Claw Forcep |
| insert | standard | Mini-Micro Dissecting Forcep |
| insert | bariatric | Mini-Micro Dissecting Forcep |
| insert | standard | Curved Metz Scissor |
| insert | bariatric | Curved Metz Scissor |
| insert | standard | Straight Micro Scissor |
| Length | Descriptions |
| insert | bariatric | Straight Micro Scissor |
| insert | standard | Delicate Curved Metz Scissor |
| insert | bariatric | Delicate Curved Metz Scissor |
| insert | standard | Curved Micro Scissor |
| insert | bariatric | Curved Micro Scissor |
| insert | standard | Straight Metz Scissor |
| insert | bariatric | Straight Metz Scissor |
| insert | standard | Flat Dissector |
| insert | bariatric | Flat Dissector |
| insert | standard | Hook Scissor |
| insert | bariatric | Hook Scissor |
| insert | standard | Delicate S/A Scissor |
| insert | bariatric | Delicate S/A Scissor |
| insert | standard | Serrated Scissor |
| insert | bariatric | Serrated Scissor |
| insert | standard | Biopsy Scoop Forcep |
| insert | bariatric | Biopsy Scoop Forcep |
| insert | standard | Biopsy Forcep w/ One Tooth |
| insert | bariatric | Biopsy Forcep w/ One Tooth |
| insert | standard | Glassman Forcep, 20mm |
| insert | bariatric | Glassman Forcep, 20mm |
| insert | standard | Heavy Curved Dissector |
| insert | bariatric | Heavy Curved Dissector |
| insert | standard | Dorsey Grasper, 40mm |
| Length | Descriptions |
| insert | bariatric | Dorsey Grasper, 40mm |
| insert | standard | Tenaculum, 5mm |
| insert | bariatric | Tenaculum, 5mm |
| insert | standard | Medium Curved Dissector |
| insert | bariatric | Medium Curved Dissector |
| insert | standard | Bump Grasper, Single Action |
| insert | bariatric | Bump Grasper, Single Action |
| insert | standard | Single Tooth Grasper |
| insert | bariatric | Single Tooth Grasper |
| insert | standard | Glassman Forcep, 30mm |
| insert | bariatric | Glassman Forcep, 30mm |
| insert | standard | Fenestrated Bowel Grasper, 20mm |
| insert | bariatric | Fenestrated Bowel Grasper, 20mm |
| insert | standard | Single Action Needle Holder |
| insert | bariatric | Single Action Needle Holder |
| insert | standard | Suture Knot Pusher |
| insert | bariatric | Suture Knot Pusher |
| insert | standard | Credi Curved Dissector |
| insert | bariatric | Credi Curved Dissector |
| insert | standard | St. Joseph Dissecting Forcep |
| insert | bariatric | St. Joseph Dissecting Forcep |
| insert | standard | Atraumatic Wave Grasper |
| insert | bariatric | Atraumatic Wave Grasper |
| insert | standard | Curved Debakey Tissue Forcep |
| Length | Descriptions |
| insert | bariatric | Curved Debakey Tissue Forcep |
| insert | standard | Petrovich Curved Dissector |
| insert | bariatric | Petrovich Curved Dissector |
| insert | standard | Andrew Babcock Forcep |
| insert | bariatric | Andrew Babcock Forcep |
| insert | standard | Maryland with Cross Serrations |
| insert | bariatric | Maryland with Cross Serrations |
| insert | standard | Fenestrated Bowel Grasper, 40mm |
| insert | bariatric | Fenestrated Bowel Grasper, 40mm |
| insert | standard | Byerley Grasper |
| insert | bariatric | Byerley Grasper |
| insert | standard | Murray Grasper |
| insert | bariatric | Murray Grasper |
| insert | standard | Double Action Spoon Forcep, 5mm |
| insert | bariatric | Double Action Spoon Forcep, 5mm |
| insert | standard | Biopsy Forcep w/ One Tooth (on
| insert | bariatric | Biopsy Forcep w/ One Tooth (on
| insert | standard | 5mm Smoot Endo Cinch |
| insert | bariatric | 5mm Smoot Endo Cinch |
| insert | standard | Single Action Spoon Forcep |
| insert | bariatric | Single Action Spoon Forcep |
| insert | standard | Harvey Grasper |
| insert | bariatric | Harvey Grasper |
| Length | Descriptions |
| insert | standard | Rodriguez Grasper |
| insert | bariatric | Rodriguez Grasper |
| insert | standard | Forsythe Bump Grasper, Single Action |
| insert | bariatric | Forsythe Bump Grasper, Single Action |
| insert | standard | Angled Dissector |
| insert | bariatric | Angled Dissector |
| insert | standard | 5mm Meah Grasper |
| insert | bariatric | 5mm Meah Grasper |
| insert | standard | Kowalski Hunter Bowel Grasper |
| insert | bariatric | Kowalski Hunter Bowel Grasper |
| insert | standard | Devlin Microfenestrated Grasper |
| insert | bariatric | Devlin Microfenestrated Grasper |
| insert | standard | Holmes Atraumatic Grasper |
| insert | bariatric | Holmes Atraumatic Grasper |
| insert | standard | Graves Grasper |
| insert | bariatric | Graves Grasper |
| insert | standard | 5mm Maryland with 90 Degree Tooth |
| insert | bariatric | 5mm Maryland with 90 Degree Tooth |
| handle/tube | standard | Take Apart Slide Lock with Rotation |
| handle/tube | bariatric | Take Apart Slide Lock with Rotation |
| handle/tube | standard | Take Apart Slide Lock with Rotation |
| handle/tube | bariatric | Take Apart Slide Lock with Rotation |
| handle/tube | standard | Monopolar Handle with Rotation,
| handle/tube | bariatric | Monopolar Handle with Rotation |
| Length | Descriptions |
| | | Ratchet on Demand |
| handle/tube | standard | Monopolar Handle with Non-Locking
| handle/tube | bariatric | Monopolar Handle with Non-Locking

Below is a complete listing of laparoscopic instruments covered by this 510(k) submission:

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