Amerigel Ointment Saturated Wound Dressing

510(k) K971918

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

11 closed

Documents

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK971918	Date12 Aug 1997Cleared	StatusActive

11 recalls · FDA

- Terminated Z-1797-2015 FDA Class II initiated 25 Feb 2015
Nonapproved labeling claims (Sterile)
4 recalls, same reason
- Terminated Z-0499-2015 FDA Class II initiated 26 Sep 2014
- Terminated Z-0498-2015 FDA Class II initiated 26 Sep 2014
- Terminated Z-0497-2015 FDA Class II initiated 26 Sep 2014
- Terminated Z-0500-2015 FDA Class II initiated 26 Sep 2014
Formulation deviation
4 recalls, same reason
- Terminated Z-2638-2014 FDA Class II initiated 11 Jul 2014
- Terminated Z-2641-2014 FDA Class II initiated 11 Jul 2014
- Terminated Z-2639-2014 FDA Class II initiated 11 Jul 2014
- Terminated Z-2640-2014 FDA Class II initiated 11 Jul 2014
Not approved labeling claims (antimicrobial and autolytic debridement)
2 recalls, same reason
- Terminated Z-1992-2014 FDA Class II initiated 21 Mar 2014
- Terminated Z-1993-2014 FDA Class II initiated 21 Mar 2014
Product may not have been manufactured pursuant to a validated process protocol and CGMP.

1 jurisdiction

United States — FDA 510(k) Active

510(k)