FDA 510(k)

纤维状胶原蛋白伤口敷料

K号: K213341 · 2022-05-31

决定日期2022-05-31

产品代码KGN

决定实质等同

器械摘要

Fibrillar Collagen Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Collagen Matrix, Inc.. It received FDA 510(k) clearance on 2022-05-31 under 510(k) number K213341. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常见问题

What is the Fibrillar Collagen Wound Dressing?

Fibrillar Collagen Wound Dressing is a medical device that received FDA 510(k) clearance on 2022-05-31. The listed applicant is Collagen Matrix, Inc.. The 510(k) number is K213341.

When did Fibrillar Collagen Wound Dressing receive FDA 510(k) clearance?

Fibrillar Collagen Wound Dressing received FDA 510(k) clearance on 2022-05-31, under 510(k) number K213341.

Who is the listed applicant for Fibrillar Collagen Wound Dressing?

The FDA 510(k) record lists Collagen Matrix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fibrillar Collagen Wound Dressing?

The FDA product code for Fibrillar Collagen Wound Dressing is KGN.

列明Collagen Matrix, Inc.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。

K251191胶原Dura再生膜 - 修复 K243071牛真皮胶原蛋白真皮基质 K242302RejuvaKnee® 胶原纤维软骨植入物 K233203软组织增强可吸收基质 K240424矿物胶原蛋白复合生物活性可塑模具骨移植基质 K231942矿物胶原蛋白复合生物活性可塑模具

查看所有 16 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.

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