FDA 510(k)

CollOvine™ 创面敷料

K号: K242985 · 2025-06-20

决定日期2025-06-20

产品代码KGN

决定实质等同

器械摘要

CollOvine™ Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Ovigenex, LLC. It received FDA 510(k) clearance on 2025-06-20 under 510(k) number K242985. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常见问题

What is the CollOvine™ Wound Dressing?

CollOvine™ Wound Dressing is a medical device that received FDA 510(k) clearance on 2025-06-20. The listed applicant is Ovigenex, LLC. The 510(k) number is K242985.

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

CollOvine™ Wound Dressing received FDA 510(k) clearance on 2025-06-20, under 510(k) number K242985.

Who is the listed applicant for CollOvine™ Wound Dressing?

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

What is the FDA product code for CollOvine™ Wound Dressing?

The FDA product code for CollOvine™ Wound Dressing is KGN.

列明Ovigenex, LLC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。

K253140CollOvine™ 创面粉

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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