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Sheffield Pharmaceuticals (Sterile) Lubrigel

by Sheffield Industries, Div. of Faria, Ltd.

510(k) K073684

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK073684 Date22 May 2008ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1953-2015 FDA Class II initiated 27 Apr 2015 on shared 510(k) K073684

    Recovery of high count of gram positive rods including single colonies of B. cepacia.

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  • Withdrawn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
KMJ
FDA applicant
Sheffield Industries, Div. of Faria , Ltd.
Device Class
Class I
Regulation
21 CFR Part 880.6375
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent