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Amerigel Ointment

by Amerx Health Care Corp.

510(k) K970133

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)SN Traditional NumberK970133 Date14 Apr 1997DecidedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-2249-2016 FDA Class II initiated 20 May 2016 on shared 510(k) K970133

    Product did not meet specifications for Zinc Acetate (OOS).

    • Terminated Z-1797-2015 FDA Class II initiated 25 Feb 2015

    Nonapproved labeling claims (Sterile)

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  • Withdrawn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
MGQ
Device Class
U
Advisory Committee
Unknown
FDA Decision
SN

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