# K132891: Hydrolyzed Collagen/AG Wound Gel with Silver

- Pathway: 510(k) (Traditional)
- Applicant: The Hymed Group Corp.
- Decided: Jun 19, 2014 after 276 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K973688 (1997). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073019: Silvermed Antimicrobial Silver Hydrogel, Argentis Biomedical Incorporated (2008) Summary page 1.

## Indications for use
Indications for Over-the-Counter Use: Hydrolyzed Collagen/Ag Wound Gel is indicated for the management of minor bums, superficial cuts, lacerations, abrasions and minor irritation of the skin. Indications for Prescription Use: Under the supervision of a healthcare professional, it is indicated for partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree bums, abrasions, lacerations, skin tears, grafted wounds, donor sites and surgical wounds.

Source page: https://510kreport.com/device/K132891
Methodology: https://510kreport.com/methodology