# K100927: Surgiaid

- Pathway: 510(k) (Traditional)
- Applicant: Maxigen Biotech, Inc.
- Decided: Feb 2, 2011 after 303 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 K925545 (1993). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925545: Skintemp, Modification, Biocore (1993) Summary page 1.

## Most influential descendants
- K223126: SurgiAid® Collagen Wound Dressing (2023), 0 descendants of its own
- K102946: Coreleader Colla-Pad Model CS 03030 (2011), 0 descendants of its own

## Indications for use
SurgiAid Collagen Wound Dressing is intended for use in patients who have surgical wounds, donor sites/grafts podiatric wounds, 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/K100927
Methodology: https://510kreport.com/methodology
