# K061474: Collawound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Collamatrix Co., Inc.
- Decided: Jul 5, 2006 after 36 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: 6 generations back to K921895 (1992). 30 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021637: Acell Ubm Lyophilized Wound Dressing, Acell, Inc. (2002) Summary page 2.
- K011026: Fortaderm Wound Dressing, Organogenesis, Inc. (2001)
- K020732: SS Matrix, Cook Biotech, Inc. (2002) Summary page 2.
- K030921: Collagen Topical Wound Dressing, Collagen Matrix, Inc. (2003) Summary page 2.
- K012990: Collatek Powder, Biocore Medical Technologies, Inc. (2001) Summary page 2.
- K910944: Medifil, Biocore (1991) Summary page 2.

## Most influential descendants
- K090894: Collawound Wound Dressing (2009), 2 descendants of its own
- K162348: ABCcolla Collagen Matrix (2017), 1 descendant of its own
- K233378: ABCcolla® Collagen ADM Scaffold (2024), 0 descendants of its own

## Indications for use
CollaWound TM dressing is intended for the management of partial and full-thickness exudating wounds including: - Pressure ulcers - Venous ulcers - Vascular ulcers - Diabetic ulcers - Trauma wounds (abrasions, lacerations, skin tears) - First and second degree bums - Surgical wounds

Source page: https://510kreport.com/device/K061474
Methodology: https://510kreport.com/methodology