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Gmd Universal Sling, Model Product Code 1010 and 1020

by Generic Medical Device, Inc.

510(k) K083471

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 NumberK083471 Date3 Mar 2009ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1390-2011 FDA Unclassified (pre-2012) initiated 14 Feb 2011 on shared 510(k) K083471

    Protective sheath sticks to itself and sleeve breakage has resulted in complaints and MDRs.

    • Terminated Z-0268-2010 FDA Unclassified (pre-2012) initiated 18 Jun 2009 on shared 510(k) K083471

    Product that is approved only for use outside the U.S. was shipped to two customers in the U.S.

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  • Withdrawn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
OTN
Device Class
Class II
Regulation
21 CFR Part 878.3300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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