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Wgl Endoscopic Grasper

by Wilson Greatbatch Technologies, Inc.

510(k) K950063

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK950063 Date27 Jan 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GCJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Wgl Endoscopic Grasper is a medical device used for grasping in endoscopic procedures. It is classified under the product code GCJ. The device is substantially equivalent and has a classification name of Laparoscope, General & Plastic Surgery. It is used in the medical specialty of Gastroenterology/Urology.

The Wgl Endoscopic Grasper is supplied by Wilson Greatbatch Technologies, Inc. and has received FDA 510(k) clearance. It is available with a product code of GCJ and has been reviewed by the Gastroenterology and Urology advisory committee. The device is used in various settings and is stored according to standard medical device storage procedures.

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Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the WGL Endoscopic Grasper used for?

    The WGL Endoscopic Grasper is used for grasping in endoscopic procedures, specifically in the medical specialty of Gastroenterology/Urology.

  • How is the WGL Endoscopic Grasper supplied?

    The WGL Endoscopic Grasper is supplied by Wilson Greatbatch Technologies, Inc.

  • What is the storage procedure for the WGL Endoscopic Grasper?

    The WGL Endoscopic Grasper is stored according to standard medical device storage procedures.

  • What is the product code for the WGL Endoscopic Grasper?

    The product code for the WGL Endoscopic Grasper is GCJ.