FDA 510(k)

胶原伤口敷料

K号: K231152 · 2023-10-12

决定日期2023-10-12

产品代码KGN

决定实质等同

器械摘要

Collagen Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Winner Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-10-12 under 510(k) number K231152. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常见问题

What is the Collagen Wound Dressing?

Collagen Wound Dressing is a medical device that received FDA 510(k) clearance on 2023-10-12. The listed applicant is Winner Medical Co., Ltd.. The 510(k) number is K231152.

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

Collagen Wound Dressing received FDA 510(k) clearance on 2023-10-12, under 510(k) number K231152.

Who is the listed applicant for Collagen Wound Dressing?

The FDA 510(k) record lists Winner Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Collagen Wound Dressing?

The FDA product code for Collagen Wound Dressing is KGN.

列明Winner Medical Co., Ltd.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。

K252001胶原伤口敷料 K250082手术面罩/外科口罩/口罩 K231057抗菌凝胶伤口敷料 K231564皮肤和伤口清洁剂 K221311抗菌绷带 K223232手术面罩/外科口罩/口罩

查看所有 18 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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