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Cook Wire Guides

by Cook Urological, Inc.

510(k) K082536

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 NumberK082536 Date27 Oct 2008ClearedStatusActive

Recalls

7 recalls · 1 ongoing · FDA

    • Ongoing Z-1837-2022 FDA Class II initiated 16 Aug 2022

    Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

  • 6 recalls, same reason

    • Terminated Z-0963-2020 FDA Class II initiated 4 Jan 2019
    • Terminated Z-0962-2020 FDA Class II initiated 4 Jan 2019
    • Terminated Z-0964-2020 FDA Class II initiated 4 Jan 2019
    • Terminated Z-0961-2020 FDA Class II initiated 4 Jan 2019
    • Terminated Z-0960-2020 FDA Class II initiated 4 Jan 2019
    • Terminated Z-0959-2020 FDA Class II initiated 4 Jan 2019

    The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

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  • Withdrawn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
OCY
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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