N/A Of-Z5K

• • 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.

Generic Name

Seizure bite block

Model / Reference

OF-Z5K

Primary DI / UDI-DI

04961333244171

510(k) Number

K850020 ↗

FDA Product Code

FDS

GMDN Term

Seizure bite block

Device Class

Class II

Regulation Number

876.1500

GUDID distribution status

In Commercial Distribution

Category: Seizure bite block

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