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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 the device name listed in this FDA 510(k) record. The listed applicant is Medskin Solutions Dr. Suwelack AG. It received FDA 510(k) clearance on 2025-12-19 under 510(k) 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. The listed applicant is Medskin Solutions Dr. Suwelack AG. The 510(k) number is K250864.

When did MatriDerm pluS+ Bi-Layer receive FDA 510(k) clearance?

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

Who is the listed applicant for MatriDerm pluS+ Bi-Layer?

The FDA 510(k) record lists Medskin Solutions Dr. Suwelack AG as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Medskin Solutions Dr. Suwelack AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261224MatriDermK201577MatriDerm

Related Devices (Code: KGN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260596Collagen Wound PowderVentris MedicalK260669Endoform Dermal TemplateAroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, Inc.K254034Roosin Collagen PowderRoosin Medical Co., Ltd.K253974Roosin Collagen DressingRoosin Medical Co., Ltd.

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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