# K110318: Excellagen

- Pathway: 510(k) (Traditional)
- Applicant: Tissue Repair Company
- Decided: Oct 3, 2011 after 243 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: 5 generations back to K881854 (1988). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072113: Integra Flowable Wound Matrix, Model FWD301, Integra Lifesciences Corp. (2007) Summary page 1.
- K030774: Stimulen Collagen, Southwest Technologies, Inc. (2004) Summary page 1.
- K910944: Medifil, Biocore (1991) Summary page 1.
- K955506: Hycure, The Hymed Group Corp. (1996) Summary page 1.
- K012990: Collatek Powder, Biocore Medical Technologies, Inc. (2001) Summary page 1.
- K990086: Heliderm Collagen Wound Dressings 0.5 Gram and 1.0 Gram, Integra Lifesciences Corp. (1999) Summary page 1.

## Indications for use
Excellagen is indicated 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-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds. This device is packaged for one-time use.

Source page: https://510kreport.com/device/K110318
Methodology: https://510kreport.com/methodology