FDA 510(k)

MiroTract 伤口基质

K号: K231614 · 2023-12-13

决定日期2023-12-13

产品代码KGN

决定实质等同

器械摘要

MiroTract Wound Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Reprise Biomedical, Inc.. It received FDA 510(k) clearance on 2023-12-13 under 510(k) number K231614. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常见问题

What is the MiroTract Wound Matrix?

MiroTract Wound Matrix is a medical device that received FDA 510(k) clearance on 2023-12-13. The listed applicant is Reprise Biomedical, Inc.. The 510(k) number is K231614.

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

MiroTract Wound Matrix received FDA 510(k) clearance on 2023-12-13, under 510(k) number K231614.

Who is the listed applicant for MiroTract Wound Matrix?

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

What is the FDA product code for MiroTract Wound Matrix?

The FDA product code for MiroTract Wound Matrix is KGN.

列明Reprise Biomedical, 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。

K240753Miro3D 纤维伤口基质 K240277MiroDry 伤口基质 K221520Miro3D 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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