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.

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.

AI/ML Overview

The provided document is a 510(k) Summary for the Endoplus Hand-held Laparoscopic Instruments. This type of document is for demonstrating substantial equivalence to a predicate device, not typically for reporting on detailed clinical studies with specific acceptance criteria, sample sizes, and expert adjudications as might be found for a novel AI/software medical device.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a diagnostic or AI-driven device is not applicable to this document.

The document focuses on comparing the Endoplus instruments to a predicate device (Pajunk GmbH Medizintechnologie's disposable inserts for handled instrument and HF Electrodes, K062072) based on indications for use, technological characteristics, and various safety and performance testing.

Here's a summary of the information that is available in the document, framed in relation to product validation rather than AI performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a table of specific acceptance criteria in the sense of quantitative thresholds for performance metrics. Instead, it lists various "Safety Testing" and "Performance Testing" studies that were conducted to demonstrate the device's safety and effectiveness and its substantial equivalence to the predicate. The "reported device performance" is implicitly that the device met the requirements of these tests, leading to the conclusion of substantial equivalence.

Category	Specific Tests Performed	Implied "Acceptance Criteria" / Performance
Safety Testing	Electrical and EMC Testing: - IEC 60601-1: 2012 3rd edition - IEC 60601-1-2 Edition 3: 2007-03 - IEC 60601-2-2: 2009	Complies with IEC standards
Cleaning & Sterilization	- 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	Demonstrates effective cleaning and sterilization; maintains integrity over shelf life.
Biocompatibility	(In accordance with ISO 10993-1, for externally communicating devices in contact with circulating blood for < 24 hours) - Cytotoxicity - Sensitization - Irritation - Systemic Toxicity - Intracutaneous - Hemolysis	Complies with ISO 10993-1; non-toxic, non-irritating, etc.
Performance Testing	- PLTW Comparative Ex-Vivo Thermal Tissue Testing Validation Study - Electrical Safety Validation Report (Electrical Safety Testing) - Scissors Performance Testing - Expected Life Testing	Performs as intended for surgical use (cutting, grasping, cauterization); safe electrically; durable over expected life.

2. Sample size used for the test set and data provenance:

This information is not provided in the document. The studies mentioned are primarily bench testing, ex-vivo testing, and compliance with standards, rather than clinical trials with patient-specific test sets. No mention of data provenance (country of origin, retrospective/prospective) is made as it's not relevant to this type of device submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. "Ground truth" in the diagnostic/AI sense is not relevant here. The evaluation is against engineering standards and functional performance, not clinical expert consensus.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI/diagnostic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. The "ground truth" for this device's performance relies on engineering specifications, recognized standards (IEC, ISO, AAMI), and functional testing results.

8. The sample size for the training set:

Not applicable. This is not a machine learning device.

9. How the ground truth for the training set was established:

Not applicable.

Conclusion from the document:
The document concludes that the Endoplus Hand-held Laparoscopic instruments are "substantially equivalent to the predicate device and introduces no new issues of safety and effectiveness" based on the described safety, cleaning, sterilization, biocompatibility, and performance testing.

Summary

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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

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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)

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

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510(k) Summary

SPONSOR
Company Name:	ENDOPLUS
Company Address	750 Tower Road, Suite AMundelelin, 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 forhandled instrument and HFElectrodes	K062072

DEVICE DESCRIPTION

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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 heldLaparoscopicinstruments areintended forgrasping, cutting,dissecting,retracting, clamping,biopsy, and/orcauterization oftissue. The devicesare used inconjunction with alaparoscope duringlaparoscopicprocedures.Instruments should beused only by personnelcompletely familiarwith their operation.Using an instrumentimproperly for a taskwhich it was notintended may result ina damaged or brokeninstrument.	Pajunks disposableinserts are instrumentsinsulated for optionalmonopolar coagulationwhich enable a surgeonto grasp, manipulate,dissect, retrieve,biopsy, cut orcoagulate internaltissue or organs whileperforminglaparoscopicprocedures.	Similar
User Environment	For use by physicianin the operatingroom	For use by physicianin the operatingroom	Identical
Monopolar	Yes	Yes	Identical
Length	20cm to 50cm	33cm to 45cm	Similar
Minimum CannulaSize	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
ArticulatingComponent	Does not articulate	Does not articulate	Identical
ActuationMechanism	Handle Operationcauses opening andclosing of endeffector	Handle Operationcauses opening andclosing of endeffector	Identical
Flush Port	Yes	No	Different
Insertion throughtrocar	Yes	Yes	Identical
Form inserted intotrocar	Jaws closed	Jaws closed	Identical
Reusable/Disposable	Reusable Handle,Shaft and Insert	Disposable InsertReusable Handle andShaft Assembly	Different

SUBSTANTIALLY EQUIVALENCE COMPARISON TABLE

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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.

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

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

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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).