FDA 510(k)

Endoform Topical Matrix

K号: K171231 · 2017-06-14

决定日期2017-06-14

产品代码KGN

决定实质等同

器械摘要

Endoform Topical Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Aroa Biosurgery. It received FDA 510(k) clearance on 2017-06-14 under 510(k) number K171231. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常见问题

What is the Endoform Topical Matrix?

Endoform Topical Matrix is a medical device that received FDA 510(k) clearance on 2017-06-14. The listed applicant is Aroa Biosurgery. The 510(k) number is K171231.

When did Endoform Topical Matrix receive FDA 510(k) clearance?

Endoform Topical Matrix received FDA 510(k) clearance on 2017-06-14, under 510(k) number K171231.

Who is the listed applicant for Endoform Topical Matrix?

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

What is the FDA product code for Endoform Topical Matrix?

The FDA product code for Endoform Topical Matrix is KGN.

列明Aroa Biosurgery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。

K172318Endoform Silver Dermal Template

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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