# K953853: Iamin Gel Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Procyte Corp.
- Decided: Feb 5, 1996 after 173 days
- Product code: MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Mar 26, 2015 · Class II · Z-1516-2015: The labeling for the Iamin family of medical devices (e.g. printed and internet text) is not consistent with the intended uses and limitations identified at the time of the clearance to market these d

Source page: https://510kreport.com/device/K953853
Methodology: https://510kreport.com/methodology