Disposable Endoscopic Retrieval Device

• • Terminated Z-1453-2015 FDA Class II ·initiated 10 Mar 2015 ·on shared 510(k) K962676

  A wire component on the distal grasping assembly of the device became detached..

• • Terminated Z-0006-2013 FDA Class II ·initiated 14 Nov 2011

  When the outer catheter is either coiled or in a contorted configuration outside of the endoscope and the patient, and excessive force is applied to the handle, the jaws may become inoperable and may become stuck in the open condition.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K962676 ↗

FDA Product Code

FGO

Device Class

Class II

Regulation

21 CFR Part 876.4680

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• U.S. Endoscopy Pull Peg Kit & U.S. Endoscopy Guidewire Peg Kit

  Class II

  FDA 510(k) K955248 Active Cleared 21 May 1996

• Concentric Balloon Google

  Class II

  FDA 510(k) K112698 Active Cleared 18 May 2012

• Disposable Overtube

  Class II

  FDA 510(k) K040836 Active Cleared 10 Jun 2004

• Coaxial Needle

  Class II

  FDA 510(k) K971842 Active Cleared 20 Jun 1997

• Papillotome

  Class II

  FDA 510(k) K962346 Active Cleared 8 Aug 1996

• Biopsy Forceps, Electric

  Class II

  FDA 510(k) K925361 Active Cleared 29 Mar 1993

See all devices from United States Endoscopy Group, Inc. →