# K061227: Hydrolyzed Collagen/AG Wound Gel with Silver

- Pathway: 510(k) (Special)
- Applicant: The Hymed Group Corp.
- Decided: Dec 20, 2006 after 232 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: 4 generations back to K973688 (1997). 14 ancestors in all.
21 later devices descend from it; 2 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955506: Hycure, The Hymed Group Corp. (1996) Summary page 1.
- K990086: Heliderm Collagen Wound Dressings 0.5 Gram and 1.0 Gram, Integra Lifesciences Corp. (1999) Summary page 1.
- K040019: Silverseal, Noble Fiber Technologies (2004) Summary page 1.
- K011994: Acryderm Silver Anttimicrobial Wound Gel Model# a-002101, Acrymed, Inc. (2001) Summary page 1.

## Most influential descendants
- K090160: Suprathel Wound and Burn Dressing (2009), 18 descendants of its own
- K132397: Gore Bio-a Wound Matrix (2014), 10 descendants of its own
- K142879: BTM Wound Dressing (2015), 5 descendants of its own
- K172140: NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm) (2017), 4 descendants of its own
- K170300: Restrata Wound Matrix (2017), 4 descendants of its own

## Indications for use
Pressure ulcers (Stages I - IV) Venous stasis ulcers Diabetic ulcers Ulcers resulting from arterial insufficiency Surgical wounds Traumatic wounds First and second degree burns Superficial wounds Grafted wounds and donor sites

Source page: https://510kreport.com/device/K061227
Methodology: https://510kreport.com/methodology