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G-Cath Tissue Anchor Delivery Catheter, Models 205302, 205333

FDA 510(k)

Class II (US FDA 510(k))

510(k) K100251

by USGI Medical

Identifiers

510(k) Number
K100251 FDA 510(k)
FDA Product Code
GAT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.5000 FDA 510(k)
Regulation Number
878.5000 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The G-Cath Tissue Anchor Delivery Catheter is a medical device designed for soft tissue approximation during minimally invasive gastroenterology procedures. It is specifically indicated for use in fistula closure, the repair of dilated gastric tissue, and the closure of perforations or leaks.

This device is supplied for clinical use as part of a system that includes an anchor pair for tissue approximation with tactile cinching capability. It has received FDA 510(k) clearance for its intended applications. Users should refer to the specific model numbers 205302 and 205333 for identification.

Frequently asked questions

What is the primary clinical application for the G-Cath Tissue Anchor Delivery Catheter?

This device is intended for soft tissue approximation during minimally invasive gastroenterology procedures. It is specifically indicated for the repair of dilated gastric tissue, the closure of perforations or leaks, and fistula closure.

How does the G-Cath system function during a procedure?

The device is supplied as part of a system that utilizes an anchor pair to approximate tissue. It features tactile cinching capability, allowing the clinician to secure the tissue effectively during the repair process.

Which specific models are available for this delivery catheter?

The G-Cath Tissue Anchor Delivery Catheter is available in two specific models, identified as 205302 and 205333. Clinicians should refer to these model numbers to ensure they are selecting the correct equipment for their specific procedural requirements.

What is the regulatory status of the G-Cath system?

The G-Cath Tissue Anchor Delivery Catheter has received FDA 510(k) clearance. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices for its intended applications.

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-cath Tissue Anchor Delivery Catheter, Models 205302, 205333, G-cath Tissue Anchor Delivery Catheter, Models 205302, 205333 510 (k ..., G-cath Tissue Anchor Delivery Catheter, Models 205302, 205333, Products — USGI Medical Website, FDA 510 (k) Applications Submitted by USGI MEDICAL

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
USGI Medical

Sources (1)

  • FDA 510(k) K100251 24 fields · synced Oct 6, 2026