# K091338: Collasorb Collagen Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Hartmann-Conco, Inc.
- Decided: Aug 26, 2009 after 112 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- 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: 1 generation back to K050177 (2005). 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)
- K050177: Colactive Collagen Wound Dressing, Covalontechnologies, Inc. (2005) Summary page 1.

## Indications for use
CollaSorbTM Collagen Wound Dressing is indicated for the management of full and partial thickness wounds including: Pressure ulcers Diabetic ulcers Ulcers caused by mixed vascular etiologies Venous ulcers Second degree burns Donor and graft sites Abrasions Dehisced surgical wounds Traumatic wounds healing by secondary intention

Source page: https://510kreport.com/device/K091338
Methodology: https://510kreport.com/methodology