meddevicedb.com FDA Device Reference

MatriDerm

K261224 Special
Decision Date
2026-05-14
Sponsor / Applicant
Medskin Solutions Dr. Suwelack AG

Technical Specification

510(k) Submission ID K261224
Product Code KGN
Medical Specialty / Panel Unknown
Decision Date 2026-05-14
Clearance Pathway Special

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

MatriDerm received FDA 510(k) clearance under submission number K261224, sponsored by Medskin Solutions Dr. Suwelack AG. The device was reviewed via the Special premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2026-05-14.

Classification & Regulation

This clearance is catalogued under FDA product code KGN , within the Unknown review panel as a device.