FDA 510(k)

MicroMatrix® Flex

K号: K230980 · 2023-09-22

决定日期2023-09-22

产品代码KGN

决定实质等同

器械摘要

MicroMatrix® Flex is the device name listed in this FDA 510(k) record. The listed applicant is Acell, Inc.. It received FDA 510(k) clearance on 2023-09-22 under 510(k) number K230980. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常见问题

What is the MicroMatrix® Flex?

MicroMatrix® Flex is a medical device that received FDA 510(k) clearance on 2023-09-22. The listed applicant is Acell, Inc.. The 510(k) number is K230980.

When did MicroMatrix® Flex receive FDA 510(k) clearance?

MicroMatrix® Flex received FDA 510(k) clearance on 2023-09-22, under 510(k) number K230980.

Who is the listed applicant for MicroMatrix® Flex?

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

What is the FDA product code for MicroMatrix® Flex?

The FDA product code for MicroMatrix® Flex is KGN.

列明Acell, 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。

K241724Cytal®伤口基质；Cytal®烧伤基质 K241706MicroMatrix® UBM Particulate K191734MatriStem UBM 心包补片 K192725Cytal伤口基质3层 K182259Gentrix 手术矩阵，Gentrix 手术矩阵膈肌 K180776Cytal伤口颗粒

查看所有 11 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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