FDA 510(k)

Derma-Gide

K号: K260532 · 2026-03-19

决定日期2026-03-19

产品代码KGN

决定实质等同

器械摘要

Derma-Gide is the device name listed in this FDA 510(k) record. The listed applicant is Geistlich Pharma AG. It received FDA 510(k) clearance on 2026-03-19 under 510(k) number K260532. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常见问题

What is the Derma-Gide?

Derma-Gide is a medical device that received FDA 510(k) clearance on 2026-03-19. The listed applicant is Geistlich Pharma AG. The 510(k) number is K260532.

When did Derma-Gide receive FDA 510(k) clearance?

Derma-Gide received FDA 510(k) clearance on 2026-03-19, under 510(k) number K260532.

Who is the listed applicant for Derma-Gide?

The FDA 510(k) record lists Geistlich Pharma AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Derma-Gide?

The FDA product code for Derma-Gide is KGN.

列明Geistlich Pharma 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。

K260364设备300419条带 K251323设备104颗粒 K252253Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®K251062Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack K251556设备300423颗粒 K251786Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®

查看所有 22 个设备 →

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

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