# Medskin Solutions Dr. Suwelack AG

- Location (FDA's records): Billerbeck, DE
- FDA decisions: 3 (2021–2026): 3 510(k) clearances
- Product codes: KGN (3)
- 510(k) review time since 2016: median 210 days, against 174 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 3 (2 its own); citations of its devices by later devices: 2 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Tei Biosciences, Inc.: 1 (https://510kreport.com/company/tei-biosciences)

## Its most-cited devices
- K201577: MatriDerm (2021), cited by 2

## Recent decisions
- K261224: MatriDerm (May 14, 2026)
- K250864: MatriDerm pluS+ Bi-Layer (Dec 19, 2025)
- K201577: MatriDerm (Jan 7, 2021)

Source page: https://510kreport.com/company/medskin-solutions-dr-suwelack