Eb-1830T3, Video Bronchoscope

• 2 recalls, same reason

  • Terminated Z-2065-2016 FDA Class II ·initiated 6 Apr 2016
  • Terminated Z-2076-2016 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-0818-2012 FDA Unclassified (pre-2012) ·initiated 30 Sep 2011

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

510(k) Number

K023376 ↗

FDA Product Code

EOQ

Device Class

Class II

Regulation

21 CFR Part 874.4680

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

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