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K Number
K193018
Device Name
Surgical Direct Hand-held Laparoscopic Instruments
Manufacturer
Surgical Direct, Inc.
Date Cleared
2019-12-20

(52 days)

Product Code
GEI
Regulation Number
878.4400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Surgical Direct Hand-held Laparoscopic Instruments are intended for grasping, dissecting, retracting, 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 SURGICAL DIRECT Hand-held Laparoscopic Instruments 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.
More Information

K151567

Not Found

No
The 510(k) summary describes standard hand-held laparoscopic instruments with mechanical linkages and does not mention any AI/ML components, image processing, or data-driven performance metrics.

Yes
The device is described as surgical instruments used for various medical procedures, including grasping, dissecting, and cauterization of tissue, which are actions intended to provide therapy or treatment to a patient.

No

The device is described as an instrument intended for surgical procedures like grasping, dissecting, retracting, clamping, biopsy, and/or cauterization of tissue, which are interventional actions rather than diagnostic ones.

No

The device description clearly states it is a physical, hand-held laparoscopic instrument with different tips/jaws and a linkage mechanism, indicating it is a hardware device. The performance studies also focus on hardware-related testing like electrical safety, cleaning, sterilization, and biocompatibility.

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, dissecting, retracting, clamping, biopsy, and/or cauterization of tissue" during laparoscopic procedures. These are all actions performed directly on the patient's body during surgery.
  • Device Description: The description details the physical nature of the instruments (tips, jaws, handle, linkage mechanism) and their function in manipulating tissue within the body.
  • Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens outside the body.

The device is a surgical instrument used in vivo (within the body) during a surgical procedure.

N/A

Intended Use / Indications for Use

Surgical Direct Hand-held Laparoscopic Instruments are intended for grasping, dissecting, retracting, 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

GEI

Device Description

The SURGICAL DIRECT Hand-held Laparoscopic Instruments 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

Safety 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
  • EMC Validation Test

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

No clinical study was conducted.

Key results: Surgical Direct concludes that the Surgical Direct Hand-held Laparoscopic Instruments are substantially equivalent to the predicate device and introduces no new issues of safety and effectiveness.

Key Metrics

Not Found

Predicate Device(s)

K151567

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 20, 2019

Surgical Direct, Inc. % E. Smith Consultant Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114

Re: K193018

Trade/Device Name: Surgical Direct 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: October 21, 2019 Received: October 29, 2019

Dear E. 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

1

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K193018

Device Name

Surgical Direct Hand-held Laparoscopic Instruments

Indications for Use (Describe)

Surgical Direct Hand-held Laparoscopic Instruments are intended for grasping, dissecting, retracting, 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)

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3

K193018 Page 1 of 11

510(k) Summary

SPONSOR

Company Name:Surgical Direct, Inc.
Address:909 South Woodland Blvd
DeLand, FL 32720
Telephone386.738.1202 Ext. 222
Email:www.surgicaldirect.com
Contact Person:David Murray
CEO/President

Summary Preparation Date: December 19, 2019

DEVICE NAME

Trade Name:SURGICAL DIRECT 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;

ManufacturerBrand Name510(k) Number
ENDOPLUSENDOPLUS Hand-heldK151567
Laparoscopic Instruments

4

K193018 Page 2 of 11

DEVICE DESCRIPTION

The SURGICAL DIRECT Hand-held Laparoscopic Instruments 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.

INDICATIONS FOR USE

Surgical Direct 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.

SURGICAL DIRECTENDOPLUSComment
Indications for Use StatementSurgical Direct 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 taskEndoplus 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 wasSame

INDICATIONS FOR USE COMPARISON TABLE

5

K193018 Page 3 of 11

SURGICAL DIRECTENDOPLUSComment
which it was not
intended may result in
a damaged or broken
instrument.not intended may result
in a damaged or broken
instrument.

PREDICATE PRODUCT COMPARISON TABLE

ParametersSURGICAL DIRECTENDOPLUSComments
510(k) NumberK151567Same
User EnvironmentFor use by physician
in the operating
roomFor use by physician
in the operating
roomSame
MonopolarYesYesSame
Length20cm to 50cm20cm to 50cmSame
Minimum Cannula
Size5.5cm5.5cmSame
Handle DesignPistol GripPistol GripSame
Shaft RotationYesYesSame
Shaft FlexibilityRigidRigidSame
Shaft Diameter5mm5mmSame
Articulating
ComponentDoes not articulateDoes not articulateSame
Actuation
MechanismHandle Operation
causes opening and
closing of end
effectorHandle Operation
causes opening and
closing of end
effectorSame
Flush PortYesYesSame
Insertion through
trocarYesYesSame
Form inserted into
trocarJaws closedJaws closedSame
Reusable/DisposableReusable Handle,
Shaft and InsertReusable Handle,
Shaft and InsertSame

DISCUSSION OF TECHNOLOGICAL DIFFERENCES

Surgical Direct Hand-held Laparoscopic Instruments are same as the Endoplus Hand held Laparoscopic instruments in indications for use, use environment, user, monopolar, length, minimum cannula size, handle design, shaft rotations, shaft flexibility, shaft diameters,

6

K193018 Page 4 of 11

articulating components, actuation mechanism, flush-port, insertion through trocar, form inserted into trocar, reusable handle, shaft and insert.

There are no differences between the SURGIAL DIRECT and the ENDOPLUS hand-held laparoscopic instruments.

PERFORMANCE DATA

Safety 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
  • EMC Validation Test

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

7

K193018 Page 5 of 11

Performance Testing:

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

CLINICAL STUDY

No clinical study was conducted.

CONCLUSION

Surgical Direct Hand-held Laparoscopic Instruments has an identical indication for use and identical technological characteristics as the predicate device. Biocompatibility testing, electrical testing and other performance tests were conducted to verify safe and effective use. Surgical Direct concludes that the Surgical Direct Hand-held Laparoscopic Instruments are substantially equivalent to the predicate device and introduces no new issues of safety and effectiveness.

| Surgical

Direct #(mm)TypeLengthDescriptions
SD89015insertStdDolphin Nose Dissecting Forceps w/ cup
SD8901455insertBariDolphin Nose Dissecting Forceps w/ cup
SD89025insertStdCurved Dissecting Forceps
SD8902455insertBariCurved Dissecting Forceps
SD89035insertStdMicro Dolphin Dissector w/ Cup
SD8903455insertBariMicro Dolphin Dissector w/ Cup
SD89045insertStdShort Curved Dissecting Forceps
SD8904455insertBariShort Curved Dissecting Forceps
SD89055insertStdMicro Dolphin Dissecting Forceps
SD8905455insertBariMicro Dolphin Dissecting Forceps
SD89065insertStdFenestrated Grasping Forceps
SD8906455insertBariFenestrated Grasping Forceps
SD89075insertStdDelicate Cone Dissector
SD8907455insertBariDelicate Cone Dissector
SD89085insertStdAlligator Forceps
SD8908455insertBariAlligator Forceps
SD89095insertStdDolphin Nose Grasping Forceps
SD8909455insertBariDolphin Nose Grasping Forceps
Surgical
Direct #(mm)TypeLengthDescriptions
SD89105insertStdStrong Fenestrated Grasping Forceps
SD8910455insertBariStrong Fenestrated Grasping Forceps
SD89115insertStdMaxi Fenestrated Grasping Forceps
SD8911455insertBariMaxi Fenestrated Grasping Forceps
SD89125insertStdDuckbill Dissector
SD8912455insertBariDuckbill Dissector
SD89135insertStdCurved Maryland Dissector
SD8913455insertBariCurved Maryland Dissector
SD89145insertStdFlat Dissector
SD8914455insertBariFlat Dissector
SD89155insertStdStraight Tapered Dissector
SD8915455insertBariStraight Tapered Dissector
SD89165insertStdMini-Micro Dissecting Forceps
SD8916455insertBariMini-Micro Dissecting Forceps
SD89175insertStdMixter Dissector
SD8917455insertBariMixter Dissector
SD89185insertStdMicro Dissecting Forceps
SD8918455insertBariMicro Dissecting Forceps
SD89195insertStdMini Right-Angle Dissector
SD8919455insertBariMini Right-Angle Dissector
SD89205insertStdStraight Mini Dissector
SD8920455insertBariStraight Mini Dissector
SD89215insertStdPointed Dissector w/ cup
SD8921455insertBariPointed Dissector w/ cup
SD89225insertStdAtraumatic Grasper S/A
SD8922455insertBariAtraumatic Grasper S/A
SD89235insertStdAtraumatic Grasper
SD8923455insertBariAtraumatic Grasper
SD89245insertStdExtracting Forceps Reverse Teeth
SD8924455insertBariExtracting Forceps Reverse Teeth
SD89255insertStdTraumatic Grasper 2x3 Teeth
SD8925455insertBariTraumatic Grasper 2x3 Teeth
SD89265insertStdCobra Jaw Grasping Forceps
SD8926455insertBariCobra Jaw Grasping Forceps
SD89275insertStdClaw Forceps 2x3 Teeth
SD8927455insertBariClaw Forceps 2x3 Teeth
Surgical
Direct #(mm)TypeLengthDescriptions
SD89285insertStdGlassman Forceps, 20mm
SD8928455insertBariGlassman Forceps, 20mm
SD89295insertStdTraumatic Grasper, 2x3 Teeth S/A
SD8929455insertBariTraumatic Grasper, 2x3 Teeth S/A
SD89305insertStdRetrograde Grasping Forceps
SD8930455insertBariRetrograde Grasping Forceps
SD89315insertStdRipple Claw Forceps
SD8931455insertBariRipple Claw Forceps
SD89325insertStdGrasping Forceps
SD8932455insertBariGrasping Forceps
SD89335insertStdGrasping Forceps w/ cup
SD8933455insertBariGrasping Forceps w/ cup
SD89345insertStdLong Grasping Forceps
SD8934455insertBariLong Grasping Forceps
SD89355insertStdOviduct Atraumatic Forceps
SD8935455insertBariOviduct Atraumatic Forceps
SD89365insertStdMcKernan Tri Grasping Fenestrated Forceps
SD8936455insertBariMcKernan Tri Grasping Fenestrated Forceps
SD89375insertStdTri-Grasper
SD8937455insertBariTri-Grasper
SD89385insertStdAtraumatic Tube Forceps
SD8938455insertBariAtraumatic Tube Forceps
SD89395insertStdWave Jaw Grasping Forceps
SD8939455insertBariWave Jaw Grasping Forceps
SD89405insertStdAllis forceps
SD8940455insertBariAllis forceps
SD89415insertStdRodriguez Grasper
SD8941455insertBariRodriguez Grasper
SD89425insertStdAngled Dissector
SD8942455insertBariAngled Dissector
SD89435insertStdBiopsy Forceps w/ Two Teeth
SD8943455insertBariBiopsy Forceps w/ Two Teeth
SD89445insertStdForsythe Bump Grasper, Single Action
SD8944455insertBariForsythe Bump Grasper, Single Action
SD89455insertStdBabcock Grasping Forceps
SD8945455insertBariBabcock Grasping Forceps
Surgical
Direct #(mm)TypeLengthDescriptions
SD89465insertStdLong Allis Forceps
SD8946455insertBariLong Allis Forceps
SD89475insertStdEndo Babcock Forceps
SD8947455insertBariEndo Babcock Forceps
SD89485insertStdPaddle Babcock
SD8948455insertBariPaddle Babcock
SD89495insertStdDebakey Tissue Forceps
SD8949455insertBariDebakey Tissue Forceps
SD89505insertStdDorsey Fenestrated Grasper
SD8950455insertBariDorsey Fenestrated Grasper
SD89515insertStdGlassman Forceps
SD8951455insertBariGlassman Forceps
SD89535insertStdRound Tip Allis Grasping Forceps
SD8953455insertBariRound Tip Allis Grasping Forceps
SD89565insertStdMedium Fenestrated Bowel Grasper
SD8956455insertBariMedium Fenestrated Bowel Grasper
SD89575insertStdEndo Allis Forceps
SD8957455insertBariEndo Allis Forceps
SD89585insertStdPennington Forceps
SD8958455insertBariPennington Forceps
SD89595insertStdAtraumatic Wave Grasper
SD8959455insertBariAtraumatic Wave Grasper
SD89605insertStdKocher Grasping Forceps
SD8960455insertBariKocher Grasping Forceps
SD89615insertStdCurved Metz Scissor
SD8961455insertBariCurved Metz Scissor
SD89625insertStdStraight Micro Scissor
SD8962455insertBariStraight Micro Scissor
SD89635insertStdDelicate Curved Metz Scissor
SD8963455insertBariDelicate Curved Metz Scissor
SD89645insertStdCurved Micro Scissor
SD8964455insertBariCurved Micro Scissor
SD89655insertStdStraight Metz Scissor
SD8965455insertBariStraight Metz Scissor
SD89665insertStdHook Scissor
SD8966455insertBariHook Scissor
Surgical
Direct #(mm)TypeLengthDescriptions
SD89675insertStdDelicate S/A Scissor
SD8967455insertBariDelicate S/A Scissor
SD89685insertStdSerrated Scissor
SD8968455insertBariSerrated Scissor
SD89695insertStdBiopsy Scoop Forceps
SD8969455insertBariBiopsy Scoop Forceps
SD89705insertStdBiopsy Forceps w/ One Tooth
SD8970455insertBariBiopsy Forceps w/ One Tooth
SD89715insertStdDorsey Grasper, 40mm
SD8971455insertBariDorsey Grasper, 40mm
SD89725insertStdSingle Tooth Grasper
SD8972455insertBariSingle Tooth Grasper
SD89735insertStdGlassman Forceps, 30mm
SD8973455insertBariGlassman Forceps, 30mm
SD89745insertStdSingle Action Needle Holder
SD8974455insertBariSingle Action Needle Holder
SD89755insertStdSuture Knot Pusher
SD8975455insertBariSuture Knot Pusher
SD89765insertStdCredi Curved Dissector
SD8976455insertBariCredi Curved Dissector
SD89775insertStdSt. Joseph Dissecting Forceps
SD8977455insertBariSt. Joseph Dissecting Forceps
SD89785insertStdCurved Debakey Tissue Forceps
SD8978455insertBariCurved Debakey Tissue Forceps
SD89795insertStdPetrovich Curved Dissector
SD8979455insertBariPetrovich Curved Dissector
SD89805insertStdFenestrated Bowel Grasper, 40mm
SD8980455insertBariFenestrated Bowel Grasper, 40mm
SD89815insertStdByerley Grasper
SD8981455insertBariByerley Grasper
SD89825insertStdMurray Grasper
SD8982455insertBariMurray Grasper
SD89835insertStdFenestrated Bowel Grasper, 20mm
SD8983455insertBariFenestrated Bowel Grasper, 20mm
SD89845insertStdBump Grasper, Single Action
SD8984455insertBariBump Grasper, Single Action
Surgical
Direct #(mm)TypeLengthDescriptions
SD89855insertStdDouble Action Spoon Forceps, 5mm
SD8985455insertBariDouble Action Spoon Forceps, 5mm
SD89865insertStdBiopsy Forceps w/ One Tooth (on bottom)
SD8986455insertBariBiopsy Forceps w/ One Tooth (on bottom)
SD89875insertStd5mm Smoot Endo Cinch
SD8987455insertBari5mm Smoot Endo Cinch
SD89885insertStdAndrew Babcock Forceps
SD8988455insertBariAndrew Babcock Forceps
SD89895insertStdTenaculum, 5mm
SD8989455insertBariTenaculum, 5mm
SD89905insertStdMaryland with Cross Serrations
SD8990455insertBariMaryland with Cross Serrations
SD89915insertStdSingle Action Spoon Forceps
SD8991455insertBariSingle Action Spoon Forceps
SD89925insertStdHarvey Grasper
SD8992455insertBariHarvey Grasper
SD89935insertStd5mm Meah Grasper
SD8993455insertBari5mm Meah Grasper
SD89945insertStdStrevy Grasper
SD8994455insertBariStrevy Grasper
SD89955insertStdMedium Curved Dissector
SD8995455insertBariMedium Curved Dissector
SD89965insertStdHeavy Curved Dissector
SD8996455insertBariHeavy Curved Dissector
SD89975insertStdJohan Forceps
SD8997455insertBariJohan Forceps
SD89985insertStdDelicate Maryland with Cross Serrations
SD8998455insertBariDelicate Maryland with Cross Serrations
SD89995insertStdMedium Dolphin Nose Dissecting Forceps w/ cup
SD8999455insertBariMedium Dolphin Nose Dissecting Forceps w/ cup
SD9025handle/tubeStdMonopolar Handle with Rotation, Ratchet on Demand
SD9035handle/tubeBariMonopolar Handle with Rotation, Ratchet on Demand
SD9045handle/tubeStdTake Apart Slide Lock with Rotation
SD9055handle/tubeBariTake Apart Slide Lock with Rotation
SD9085handle/tubeStdMonopolar Handle with Non-Locking Rotation, NO
Ratchet
Surgical
Direct #(mm)TypeLengthDescriptions
SD9095handle/tubeBariMonopolar Handle with Non-Locking Rotation, NO
Ratchet
SD9105handle/tubeStdTake Apart Slide Lock with Rotation
SD9115handle/tubeBariTake Apart Slide Lock with Rotation
SD99015insertStdKowalski Hunter Bowel Grasper
SD9901455insertBariKowalski Hunter Bowel Grasper
SD99025insertStdDevlin Micro-fenestrated Grasper
SD9902455insertBariDevlin Micro-fenestrated Grasper
SD99035insertStdHolmes Atraumatic Grasper
SD9903455insertBariHolmes Atraumatic Grasper
SD99045insertStdGraves Grasper
SD9904455insertBariGraves Grasper
SD99055insertStd5mm Maryland with 90 Degree Tooth
SD9905455insertBari5mm Maryland with 90 Degree Tooth

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

8

K193018

Page 6 of 11

9

K193018

Page 7 of 11

10

K193018

Page 8 of 11

11

K193018

Page 9 of 11

12

13