G-Prox Endoscopic Grasper, Model 205333
FDA 510(k)Class II (US FDA 510(k))
by USGI Medical
Identifiers
- 510(k) Number
- K093018 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-Prox Endoscopic Grasper is a device used in minimally invasive procedures to facilitate tissue grasping and manipulation. It is designed to grasp gastric tissue and approximate tissue folds in preparation for delivering Snowshoe Suture Anchors. This instrument functions as both an endoscopic tissue grasper and a needle driver.
The device is supplied as a single-use instrument and is not MRI compatible. It is authorized under FDA 510(k) clearance with product code GAT and K-number K093018. The device is stored according to the manufacturer's instructions and is intended for use in general and plastic surgery procedures.
Frequently asked questions
What is the G-Prox Endoscopic Grasper used for?
The G-Prox Endoscopic Grasper is designed to grasp gastric tissue and approximate tissue folds in preparation for delivering Snowshoe Suture Anchors during minimally invasive procedures. It functions as both an endoscopic tissue grasper and a needle driver.
Is the G-Prox Endoscopic Grasper reusable or single-use?
The G-Prox Endoscopic Grasper is supplied as a single-use instrument and should not be reused. It is not MRI compatible and should be stored according to the manufacturer's instructions.
What are the regulatory authorizations for the G-Prox Endoscopic Grasper?
The G-Prox Endoscopic Grasper is authorized under FDA 510(k) clearance with product code GAT and K-number K093018. It is intended for use in general and plastic surgery procedures.
What procedures is the G-Prox Endoscopic Grasper indicated for?
The G-Prox Endoscopic Grasper is intended for use in general and plastic surgery procedures where tissue grasping and manipulation are required, particularly for approximating tissue folds in preparation for delivering Snowshoe Suture Anchors.
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-PROX ENDOSCOPIC GRASPER, MODEL 205333 (K093018) - Innolitics, Products — USGI Medical Website, Usgi Medical FDA 510 (k) Products (2005-2011), G-prox Endoscopic Grasper, Model 205333 510 (k) FDA Premarket ..., USGI Medical, Inc. - endolumenalsurgery.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K093018 | Class II | Active |
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Manufacturer
- Manufacturer
- USGI Medical
Sources (1)
- FDA 510(k) K093018 24 fields · synced Sep 23, 2026