# K092805: Collagen Sponge

- Pathway: 510(k) (Traditional)
- Applicant: Innocoll Pharmaceuticals
- Decided: Feb 16, 2010 after 158 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 K910944 (1991). 9 ancestors in all.
10 later devices descend from it; 4 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)
- K061746: Collaguard, Model Fcia,Fcib,Fcic,and Fcid, Innocoll Pharmaceuticals (2006) Summary page 1.
- K081782: Collieva, Innocoll Pharmaceuticals (2008) Summary page 1.

## Most influential descendants
- K110388: Collacare Dental (2011), 6 descendants of its own
- K122115: Collagen Dental Wound Dressings (2012), 5 descendants of its own
- K152600: Collagen Dental Wound Dressings (2016), 2 descendants of its own
- K133290: Collacare Dental (2014), 1 descendant of its own
- K253758: Dental Cone; Dental Sponge (2025), 0 descendants of its own

## Indications for use
Collagen Sponge may be used for the management of wounds such as: * Pressure ulcers * Venous stasis ulcers * Diabetic ulcers * First and second degree burns * Partial and full thickness wounds * Superficial injuries

Source page: https://510kreport.com/device/K092805
Methodology: https://510kreport.com/methodology