# K213341: Fibrillar Collagen Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Collagen Matrix, Inc.
- Decided: May 31, 2022 after 236 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: 2 generations back to K910944 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030921: Collagen Topical Wound Dressing, Collagen Matrix, Inc. (2003) Summary page 4.

## Indications for use
Fibrillar Collagen Wound Dressing is indicated for the management of moderately to heavily exudating wounds and to control minor bleeding. Fibrillar Collagen Wound Dressing may be used for the management of exudating wounds such as: - Pressure ulcers - Venous stasis ulcers - Diabetic ulcers - Acute wounds, for example trauma and surgical wounds - Partial-thickness burns

Source page: https://510kreport.com/device/K213341
Methodology: https://510kreport.com/methodology