FDA 510(k)

PELNAC伤口基质

K号: K213573 · 2022-02-09

决定日期2022-02-09

产品代码KGN

决定实质等同

器械摘要

PELNAC Wound Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Gunze Limited. It received FDA 510(k) clearance on 2022-02-09 under 510(k) number K213573. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常见问题

What is the PELNAC Wound Matrix?

PELNAC Wound Matrix is a medical device that received FDA 510(k) clearance on 2022-02-09. The listed applicant is Gunze Limited. The 510(k) number is K213573.

When did PELNAC Wound Matrix receive FDA 510(k) clearance?

PELNAC Wound Matrix received FDA 510(k) clearance on 2022-02-09, under 510(k) number K213573.

Who is the listed applicant for PELNAC Wound Matrix?

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

What is the FDA product code for PELNAC Wound Matrix?

The FDA product code for PELNAC Wound Matrix is KGN.

列明Gunze Limited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。

K221487NEOVEIL缝线加固带 K213498PELNAC网状双层伤口基质 K191992PELNAC双层伤口基质

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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