# K093351: Collawound Art

- Pathway: 510(k) (Abbreviated)
- Applicant: Collamatrix, Inc.
- Decided: Jun 16, 2010 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 K970566 (1997). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051647: Fortaderm Antimicrobial Wound Dressing, Organogenesis, Inc. (2005)
- K024054: Xylos Xcell Antimicrobial Dressing, Xylos Corporation (2003) Summary page 2.

## Indications for use
CollnWound ART is a wound dressing intended for use as a barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. CohnaWound ART is intended for the management of wounds including: * partial and full thickness wounds * pressure ulcers * venous ulcers * diabetic ulcers * chronic vascular ulcers * tunneled/undermined wounds * surgical wounds (donor sites/grafts, post-Moli's surgery, post-laser surgery, wound dehiscence) * trauma wounds (abrasions, lacerations, second-degree bumns, and skin tears) * draining wounds

Source page: https://510kreport.com/device/K093351
Methodology: https://510kreport.com/methodology