# K253140: CollOvine™ Wound Powder

- Pathway: 510(k) (Traditional)
- Applicant: Ovigenex, LLC
- Decided: Feb 10, 2026 after 138 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.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030774: Stimulen Collagen, Southwest Technologies, Inc. (2004) Summary page 6.

## Indications for use
CollOvine ™ Wound Powder is indicated for the management of wounds including: - full-thickness & partial-thickness wounds • pressure ulcers • venous ulcers • diabetic ulcers • partial thickness burns • donor sites and other surface wounds • abrasions • traumatic wounds healing by secondary intention • acute wounds

Source page: https://510kreport.com/device/K253140
Methodology: https://510kreport.com/methodology