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Gyn Disposables Tenaculum 356T

by Gyn-Disposables, Inc.

510(k) K073182

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

6 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK073182 Date28 Nov 2007ClearedStatusActive

Recalls

7 recalls · 6 ongoing · FDA

  • 6 recalls, same reason

    • Ongoing Z-0130-2022 FDA Class II initiated 10 Sep 2021
    • Ongoing Z-0129-2022 FDA Class II initiated 10 Sep 2021
    • Ongoing Z-0131-2022 FDA Class II initiated 10 Sep 2021
    • Ongoing Z-0126-2022 FDA Class II initiated 10 Sep 2021
    • Ongoing Z-0127-2022 FDA Class II initiated 10 Sep 2021
    • Ongoing Z-0128-2022 FDA Class II initiated 10 Sep 2021

    Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

    • Terminated Z-3025-2011 FDA Unclassified (pre-2012) initiated 29 Jul 2011

    Lack of sterility assurance.

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  • Withdrawn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