# K231152: Collagen Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Winner Medical Co., Ltd.
- Decided: Oct 12, 2023 after 171 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 K060456 (2006). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060456: Medline Collagen Wound Dressing, Medline Industries, Inc. (2006) Summary page 5.

## Most influential descendants
- K252001: Collagen Wound Dressing (2025), 0 descendants of its own

## Indications for use
The Collagen Wound Dressing is indicated for the management of exuding wounds including: Full thickness and partial thickness wounds Pressure and venous ulcers Ulcers caused by mixed vascular etiologies Diabetic ulcers Partial thickness burns Donor sites and other bleeding surface wounds Abrasions Traumatic wound healing by secondary intention Dehisced surgical incisions

Source page: https://510kreport.com/device/K231152
Methodology: https://510kreport.com/methodology