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Fetzer Medical Gynecological Forceps

by Fetzer Medical GmbH & Co. KG

510(k) K172661

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 12 Oct 2026. What this means

Regulatory status

as of registry sync 12 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK172661 Date8 May 2018ClearedStatusActive

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0758-2019 FDA Class II initiated 28 Dec 2018 on shared 510(k) K172661
    • Terminated Z-0757-2019 FDA Class II initiated 28 Dec 2018 on shared 510(k) K172661
    • Terminated Z-0755-2019 FDA Class II initiated 28 Dec 2018 on shared 510(k) K172661
    • Terminated Z-0756-2019 FDA Class II initiated 28 Dec 2018 on shared 510(k) K172661

    The firm had a report of doctors being unable to pull the obstetric forceps apart.

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  • Withdrawn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
HCZ
Device Class
Class II
Regulation
21 CFR Part 884.4530
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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