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FDA 510(k)

ologen 胶原基质

K号: K173223 · 2018-03-02

申请人Aeon Astron Europe B.V.
决定日期2018-03-02
产品代码KGN
决定实质等同

器械摘要

ologen Collagen Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Aeon Astron Europe B.V.. It received FDA 510(k) clearance on 2018-03-02 under 510(k) number K173223. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常见问题

What is the ologen Collagen Matrix?

ologen Collagen Matrix is a medical device that received FDA 510(k) clearance on 2018-03-02. The listed applicant is Aeon Astron Europe B.V.. The 510(k) number is K173223.

When did ologen Collagen Matrix receive FDA 510(k) clearance?

ologen Collagen Matrix received FDA 510(k) clearance on 2018-03-02, under 510(k) number K173223.

Who is the listed applicant for ologen Collagen Matrix?

The FDA 510(k) record lists Aeon Astron Europe B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ologen Collagen Matrix?

The FDA product code for ologen Collagen Matrix is KGN.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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 BiomaterialsK260596胶原蛋白伤口粉Ventris MedicalK260669Endoform 皮肤模板Aroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, Inc.

官方来源

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