Fg-36UX, Ultrasound Upper Gi Fiberscope

• • Terminated Z-2077-2016 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-2279-2016 FDA Class II ·initiated 6 Apr 2016 ·on shared 510(k) K961974

  Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.

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

510(k) Number

K961974 ↗

FDA Product Code

ITX

Device Class

Class II

Regulation

21 CFR Part 892.1570

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Fe-34TH, Fiber Esophagoscope

  Class II

  FDA 510(k) K951198 Active Cleared 30 May 1995

• Eg-3630UR, Ultrasund Video Gastroscope

  Class II

  FDA 510(k) K013640 Active Cleared 4 Feb 2002

• Fs-38X, Fiber Sigmoidoscope

  Class II

  FDA 510(k) K951572 Active Cleared 27 Jun 1995

• 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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