MatriDerm— 510(k) K261224
Substantially EquivalentMedskin Solutions Dr. Suwelack AG
FDA 510(k) clearance K261224 for MatriDerm, Substantially Equivalent on 2026-05-14. Applicant: Medskin Solutions Dr. Suwelack AG. Device class: Unclassified.
Summary
Medskin Solutions Dr. Suwelack's MatriDerm is filed under KGN, wound dressings with animal-derived material(s).
Class U, with no regulation number. The classification panel is listed as Unknown, and the General and Plastic Surgery review panel handled it as a Special 510(k).
Medskin Solutions filed from Billerbeck, Germany. Review took 30 calendar days (April 14 to May 14, 2026).
Clearance details
- Applicant
- Medskin Solutions Dr. Suwelack AG
- Product code
- Product code KGN
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Billerbeck, DE
Recent devices under product code KGN
view allMore clearances from Medskin Solutions Dr. Suwelack AG
view allAdverse events under product code KGN
product code KGN- Other
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.