# K971918: Amerigel Ointment Saturated Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Amerx Health Care Corp.
- Decided: Aug 12, 1997 after 81 days
- Product code: MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic)
- Device class: U
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K970133 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970133: Amerigel Ointment, Amerx Health Care Corp. (1997) Summary page 3.

## Recalls of this device
- Feb 25, 2015 · Class II · Z-1797-2015: Nonapproved labeling claims (Sterile)
- Sep 26, 2014 · Class II · Z-0499-2015: Formulation deviation
- Sep 26, 2014 · Class II · Z-0497-2015: Formulation deviation
- Sep 26, 2014 · Class II · Z-0498-2015: Formulation deviation
- Sep 26, 2014 · Class II · Z-0500-2015: Formulation deviation
- Jul 11, 2014 · Class II · Z-2639-2014: Not approved labeling claims (antimicrobial and autolytic debridement)
- Jul 11, 2014 · Class II · Z-2641-2014: Not approved labeling claims (antimicrobial and autolytic debridement)
- Jul 11, 2014 · Class II · Z-2640-2014: Not approved labeling claims (antimicrobial and autolytic debridement)
- Jul 11, 2014 · Class II · Z-2638-2014: Not approved labeling claims (antimicrobial and autolytic debridement)
- Mar 21, 2014 · Class II · Z-1992-2014: Product may not have been manufactured pursuant to a validated process protocol and CGMP.
- Mar 21, 2014 · Class II · Z-1993-2014: Product may not have been manufactured pursuant to a validated process protocol and CGMP.

## Indications for use
For the management of open wounds. For use as a wound dressing to manage pressure ulcers stages I-IV, stasis ulcers, diabetic skin ulcers, skin irritation, cuts, abrasions and skin irritations associated with periostomal care.

Source page: https://510kreport.com/device/K971918
Methodology: https://510kreport.com/methodology