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Entax Ultrasound Video Bronchoscope Eb-1970UK + Hi Visin Preirus

by Pentax Medical Company

510(k) K131946

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK131946 Date25 Apr 2014ClearedStatusActive

Recalls

4 recalls · FDA

    • Terminated Z-0757-2017 FDA Class II initiated 31 May 2016

    The EB-1970UK Ultrasound Video Bronchoscope shipped between the clearance date of April 2014 and September 2015 contained the Operation and Reprocessing IFUs that were in use prior to the 2014 clearance, and therefore did not include the cleared Operation and Reprocessing IFUs.

  • 3 recalls, same reason

    • Terminated Z-2325-2017 FDA Class II initiated 11 Jan 2011
    • Terminated Z-2326-2017 FDA Class II initiated 11 Jan 2011
    • Terminated Z-2324-2017 FDA Class II initiated 11 Jan 2011

    This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions taken in 2010-2011.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
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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