Eg-2940, Video Gastroscope

• • 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-0819-2012 FDA Unclassified (pre-2012) ·initiated 30 Sep 2011 ·on shared 510(k) K961564

  The wrong silicone sealant was used and excess sealant was neglected to be removed during repair of the bronchoscope.

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

510(k) Number

K961564 ↗

FDA Product Code

FDS

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

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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