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Ksea Neuro-Fiberscope

by Karl Storz Endoscopy-America, Inc. 2 variants

510(k) K002788

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 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 NumberK002788 Date23 Oct 2000ClearedStatusActive

Recalls

4 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-1531-2020 FDA Class II initiated 27 Aug 2019
    • Ongoing Z-1532-2020 FDA Class II initiated 27 Aug 2019
    • Ongoing Z-1530-2020 FDA Class II initiated 27 Aug 2019

    During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray information, specified for the STERIS System 1E (SS1E) sterilization method within the instruction manual is incorrect. If the user uses SS1E to sterilize the impacted scopes and referred to the manual concerning the QCK information, the sterility of reprocessed scope cannot be guaranteed.

    • Terminated Z-2425-2019 FDA Class II initiated 20 Feb 2019

    The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port.

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  • Withdrawn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
GWG
Device Class
Class II
Regulation
21 CFR Part 882.1480
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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