Suturing Device

Suturing Device
Endo Stitch - 173016

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.

• Outer Diameter: 10 Millimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 20884521100005

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10884521100008

Package Quantity: 3

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CASE

Device Id: 10884521100008

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