Bioshield-Ercp Biopsy Valve, Model 00711138

• • Terminated Z-0861-2015 FDA Class II ·initiated 31 Oct 2014 ·via K070420, on the same 510(k)

  Packaging non-conformance related to the integrity of the sterile pouch seal.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K070420 ↗

FDA Product Code

ODD

Device Class

Class II

Regulation

21 CFR Part 876.1500

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. →