Suturing Device


Product Overview

Suturing Device
Endo Stitch - 173027


Device Description

A non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a single-use device.


Environmental Conditions

  • Handling Environment Temperature - Degrees Fahrenheit
    • 120.00
    • 0.00

  • Device Sizes

  • length,short,N/A;
  • Outer Diameter: 10 Millimeter
    • length,short,N/A;
    • Outer Diameter: 10 Millimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: OCW

    Device Name: Endoscopic Tissue Approximation Device

    Device Class: 2

    Physical State: may include: delivery instrument, applier, holder, connector, threading tool, needle-loading tool, ring implant, pin implant, knot pusher, sutures, staples, clips, tackers, fasteners

    Definition: To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.

    Submission Type ID: 1

    Review Panel: GU

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Many methods to perform intended use. Insert instrument through endoscope at desired area of delivery.

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: Various tissues located within body cavities, hollow organs, and canals in GI and GU tract.

    Regulation Number: 876.1500

    Third Party Flag: N

    Medical Specialty: GU


    Device Identifiers

    Device Id: 20884521100012

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10884521100015

    Package Quantity: 3

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: CASE


    Device Id: 10884521100015

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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