# K140820: Xenomem Wound Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Viscus Biologics, LLC
- Decided: Jun 26, 2015 after 451 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: 4 generations back to K881854 (1988). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 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 5.
- K020732: SS Matrix, Cook Biotech, Inc. (2002) Summary page 5.

## Indications for use
XenoMem™ Wound Matrix is indicated for the management of wounds including: • Partial and full-thickness wounds; • Pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers; • Tunnelled/undermined wounds • Surgical wounds (donor sites/grafts, post-Mohs’ surgery, post-laser surgery, podiatric, wound dehiscence), • Trauma wounds (abrasions, lacerations, second-degree burns, skin tears); • Draining wounds.

Source page: https://510kreport.com/device/K140820
Methodology: https://510kreport.com/methodology