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FDA 510(k)

MatriDerm pluS+ Bi-Layer

K-Number: K250864 · 2025-12-19

ApplicantMedskin Solutions Dr. Suwelack AG
Decision Date2025-12-19
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

MatriDerm pluS+ Bi-Layer is a medical device manufactured by Medskin Solutions Dr. Suwelack AG. It received FDA 510(k) clearance on 2025-12-19 under approval number K250864. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MatriDerm pluS+ Bi-Layer?

MatriDerm pluS+ Bi-Layer is a medical device that received FDA 510(k) clearance on 2025-12-19. It is manufactured by Medskin Solutions Dr. Suwelack AG. The 510(k) number is K250864.

When was MatriDerm pluS+ Bi-Layer approved by the FDA?

MatriDerm pluS+ Bi-Layer received FDA 510(k) clearance on 2025-12-19, under approval number K250864.

What company makes MatriDerm pluS+ Bi-Layer?

MatriDerm pluS+ Bi-Layer is manufactured by Medskin Solutions Dr. Suwelack AG.

What is the FDA product code for MatriDerm pluS+ Bi-Layer?

The FDA product code for MatriDerm pluS+ Bi-Layer is KGN.

Other Devices by Medskin Solutions Dr. Suwelack AG

K201577MatriDerm K261224MatriDerm

Related Devices (Code: KGN)

K160136Flowable Wound MatrixCook Biotech Incorporated K152600Collagen Dental Wound DressingsCollagen Matrix, Inc. K153754MicroMatrixAcell, Inc. K153690PriMatrix Dermal Repair ScaffoldTei Biosciences, Inc. K172010gel-e BandageGel-E, Inc. (Formerly Remedium Technologies, Inc.) K171842Geistlich Wound MatrixGeistlich Pharma AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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