# K223126: SurgiAid® Collagen Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Maxigen Biotech, Inc.
- Decided: Oct 11, 2023 after 373 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 K925545 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100927: Surgiaid, Maxigen Biotech, Inc. (2011) Summary page 4.

## Indications for use
SurgiAid Collagen Wound Dressing is indicated for use in patients who have surgical wounds, donor sites/grafts, podiatric wound, wound dehiscence, traumatic wounds, abrasions, lacerations, partial thickness burns or skin tears. SurgiAid Collagen Wound Dressing can be applied to wounds with depth less than 0.3 cm.

Source page: https://510kreport.com/device/K223126
Methodology: https://510kreport.com/methodology