# K970133: Amerigel Ointment

- Pathway: 510(k) (Traditional)
- Applicant: Amerx Health Care Corp.
- Decided: Apr 14, 1997 after 89 days
- Product code: MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic)
- Device class: U
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K971918: Amerigel Ointment Saturated Wound Dressing (1997), 0 descendants of its own

## Recalls of this device
- May 20, 2016 · Class II · Z-2249-2016: Product did not meet specifications for Zinc Acetate (OOS).
- Feb 25, 2015 · Class II · Z-1797-2015: Nonapproved labeling claims (Sterile)

Source page: https://510kreport.com/device/K970133
Methodology: https://510kreport.com/methodology