G-Cinch Suture Grasper
FDA 510(k)Class II (US FDA 510(k))
by USGI Medical
Identifiers
- 510(k) Number
- K102931 FDA 510(k)
- FDA Product Code
- OCW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The G-Cinch Suture Grasper is an endoscopic tissue approximation device intended for use with the g-Cath Tissue Anchor Delivery Catheter for suture grasping and cinching of g-Cath Tissue Anchors. It consists of a proximal polycarbonate/ABS handle, a flexible medical-grade polymer shaft, and a distal metal snare.
The device is sterile and designed for single-patient use. It is supplied as an endoscopic accessory and is regulated under FDA 510(k) clearance K102931, with product code OCW and classification under regulation number 876.1500.
Frequently asked questions
What is the G-Cinch Suture Grasper used for?
The G-Cinch Suture Grasper is intended for use with the g-Cath Tissue Anchor Delivery Catheter to grasp and cinch g-Cath Tissue Anchors during endoscopic tissue approximation procedures, enabling secure tissue closure without suturing.
Is the G-Cinch Suture Grasper sterile and for single-patient use only?
Yes, the device is supplied sterile and is designed for single-patient use only, as stated in its specifications, to prevent cross-contamination and ensure patient safety during endoscopic procedures.
What materials make up the G-Cinch Suture Grasper and how is it supplied?
The device consists of a proximal polycarbonate/ABS handle, a flexible medical-grade polymer shaft, and a distal metal snare, and is supplied as a sterile endoscopic accessory for single-patient use.
What regulatory pathway was used for the G-Cinch Suture Grasper and what is its product code?
The G-Cinch Suture Grasper received FDA 510(k) clearance under K102931 and is classified under product code OCW, with regulation number 876.1500, indicating its classification as an endoscopic tissue approximation device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: G-CINCH SUTURE GRASPER (K102931) — FDA 510(k) | Innolitics, Products — USGI Medical Website, G-cinch Suture Grasper 510 (k) FDA Premarket Notification K102931 USGI ..., PDF c3 SUMMARY OF SAFETY DEC- 3 02010
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K102931 | Class II | Active |
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Manufacturer
- Manufacturer
- USGI Medical
Sources (1)
- FDA 510(k) K102931 24 fields · synced Sep 22, 2026