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Karl Storz Rhino-Laryngo-Broncho Fiberscope, Fiberscope for Bronchoscopy

by Karl Storz Endoscopy-America, Inc.

510(k) K954797

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK954797 Date17 Jan 1996ClearedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-1472-2024 FDA Class II initiated 27 Feb 2024

    Inadequate reprocessing validation evidence

    • Terminated Z-0527-2014 FDA Class II initiated 13 Nov 2013 on shared 510(k) K954797

    KARL STORZ Endoscopy America, Inc. is recalling the Flexible Broncho Fiberscope or a Flexible Intubation Fiberscope with a suction port because the material used in the suction channel portion was thermoplastic polyurethane (TPU), which is not listed in STERRAD systems claims for interior endoscope lumens.

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

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  • Withdrawn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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