# K160136: Flowable Wound Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech Incorporated
- Decided: Sep 28, 2016 after 252 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: 1 generation back to K061711 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061711: Oasis Wound Matrix, Cook Biotech, Inc. (2006) Summary page 4.

## Indications for use
The Flowable Wound Matrix is intended 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, 2nd degree burns, skin tears), - draining wounds.

Source page: https://510kreport.com/device/K160136
Methodology: https://510kreport.com/methodology