Pentax Pne- Ultra-Slim Upper G.I. Fiberscope Fg-23

• • Terminated Z-2071-2016 FDA Class II ·initiated 6 Apr 2016

  Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

• • Terminated Z-2290-2014 FDA Class II ·initiated 17 Jul 2014 ·on shared 510(k) K850020

  The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed carefully may cause a potential risk to health.

• • Terminated Z-0084-2014 FDA Class I ·initiated 16 Sep 2013 ·on shared 510(k) K850020

  PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve. A manufacturing defect may cause improper stoppage of CO2 gas during an endoscopic procedure with the potential for serious hazard to and/or user.

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

510(k) Number

K850020 ↗

FDA Product Code

FDS

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K013640 Active Cleared 4 Feb 2002

• Fs-38X, Fiber Sigmoidoscope

  Class II

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• Kec-3840l/F, Video Colonoscope (*l or F in Model Number Denotes Length)

  Class II

  FDA 510(k) K961570 Active Cleared 24 Jun 1996

• Fcp-9P, Fiber Choledochoscope

  Class II

  FDA 510(k) K953286 Active Cleared 3 Nov 1995

• Fi-10P

  Class I

  FDA 510(k) K951195 Active Cleared 6 Apr 1995

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