FDA 510(k)

MatriDerm

K号: K261224 · 2026-05-14

决定日期2026-05-14

产品代码KGN

决定实质等同

器械摘要

MatriDerm 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 2026-05-14 under 510(k) number K261224. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常见问题

What is the MatriDerm?

MatriDerm is a medical device that received FDA 510(k) clearance on 2026-05-14. The listed applicant is Medskin Solutions Dr. Suwelack AG. The 510(k) number is K261224.

When did MatriDerm receive FDA 510(k) clearance?

MatriDerm received FDA 510(k) clearance on 2026-05-14, under 510(k) number K261224.

Who is the listed applicant for MatriDerm?

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?

The FDA product code for MatriDerm is KGN.

列明Medskin Solutions Dr. Suwelack AG为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K250864MatriDerm pluS+ 双层 K201577MatriDerm

相关器械（代码：KGN）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260652ColActive PlusCovalon Technologies, Ltd.K260711Accelagen Plus 手术基质，1cc（CG-01AP）；Accelagen Plus 手术基质，3cc（CG-03AP）；Accelagen Plus 手术基质，5cc（CG-05AP）；Accelagen Plus 手术条带，125x25x2mm（CG-125X25AP）；Accelagen Plus 手术条带，250x25x2mm（CG-250X25AP）Berkeley Advanced Biomaterials K260596胶原蛋白伤口粉Ventris Medical K260669Endoform 皮肤模板Aroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, Inc.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。