# K040211: Modification to: Collagen Topical Wound Dressing

- Pathway: 510(k) (Special)
- Applicant: Collagen Matrix, Inc.
- Decided: Feb 27, 2004 after 28 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.
14 later devices descend from it; 2 cite it directly.
0 of 20 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 1.

## Most influential descendants
- K040558: Modification to: Collagen Topical Wound Dressing (2004), 13 descendants of its own
- K061746: Collaguard, Model Fcia,Fcib,Fcic,and Fcid (2006), 12 descendants of its own
- K081782: Collieva (2008), 11 descendants of its own
- K092805: Collagen Sponge (2010), 10 descendants of its own
- K110388: Collacare Dental (2011), 6 descendants of its own

## Indications for use
Collagen Topical Wound Dressing is indicated for the management of moderately to heavily exudating wounds and to control minor bleeding. Collagen Topical 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/K040211
Methodology: https://510kreport.com/methodology