# K250329: GeniPhys Collymer Self-Assembling Scaffold

- Pathway: 510(k) (Traditional)
- Applicant: Geniphys, Inc.
- Decided: Jun 25, 2025 after 140 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: 5 generations back to K881854 (1988). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072113: Integra Flowable Wound Matrix, Model FWD301, Integra Lifesciences Corp. (2007) Summary page 5.

## Indications for use
Collymer Self-Assembling Scaffold is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/ undermined wounds, surgical wounds (donor sites/grafts, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears) and draining wounds.

Source page: https://510kreport.com/device/K250329
Methodology: https://510kreport.com/methodology