# K242985: CollOvine™ Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Ovigenex, LLC
- Decided: Jun 20, 2025 after 267 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 K881854 (1988). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982597: Fibrcol Plus Collagen Wound Dressing with Alginate, Johnson & Johnson Medical, Inc. (1998) Summary page 5.

## Indications for use
CollOvine TM Wound Dressing is indicated for the management of exuding wounds including: - full-thickness & partial-thickness wounds - pressure ulcers - venous ulcers - ulcers caused by mixed vascular etiologies - diabetic ulcers - superficial second-degree burns - donor sites and other bleeding surface wounds - abrasions - traumatic wounds healing by secondary intention - dehisced surgical incisions

Source page: https://510kreport.com/device/K242985
Methodology: https://510kreport.com/methodology