# K250864: MatriDerm pluS+ Bi-Layer

- Pathway: 510(k) (Traditional)
- Applicant: Medskin Solutions Dr. Suwelack AG
- Decided: Dec 19, 2025 after 273 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: 9 generations back to K881854 (1988). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201577: MatriDerm, Medskin Solutions Dr. Suwelack AG (2021) Summary page 5.

## Indications for use
MatriDerm pluS+ is indicated for the management of wounds including full thickness and partial thickness wounds, chronic wounds (e.g. pressure ulcers, venous ulcers, diabetic ulcers, chronic ulcers), surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), partial thickness burns, trauma wounds (abrasions, lacerations and skin tears) and draining wounds.

Source page: https://510kreport.com/device/K250864
Methodology: https://510kreport.com/methodology