FDA 510(k)

Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®

K号: K252253 · 2025-11-25

决定日期2025-11-25

产品代码NPL

咨询委员会DE 请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。

决定实质等同

器械摘要

Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-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 2025-11-25 under 510(k) number K252253. The device is classified under product code NPL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®?

Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® is a medical device that received FDA 510(k) clearance on 2025-11-25. The listed applicant is Geistlich Pharma AG. The 510(k) number is K252253.

When did Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® receive FDA 510(k) clearance?

Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® received FDA 510(k) clearance on 2025-11-25, under 510(k) number K252253.

Who is the listed applicant for Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-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 Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®?

The FDA product code for Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® is NPL.

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 K260532Derma-Gide K251323设备104颗粒 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：NPL）

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。

K242817Jason 膜Botiss Biomaterials GmbH K250512增强牙龈基质Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.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 PackGeistlich Pharma AG K250833SwissMembrane X；SwissMembrane X 插座Geistlich Pharma AG K233203软组织增强可吸收基质Collagen Matrix, Inc.K231513口腔基质Beijing Biosis Healing Biolog Ical Technology Co., Ltd.

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。