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FDA 510(k)

INTEGRA Wound Matrix（大通道）

K号: K210128 · 2021-10-08

申请人Integra LifeSciences Corporation
决定日期2021-10-08
产品代码KGN
决定实质等同

器械摘要

INTEGRA Wound Matrix (Macro-Channels) is the device name listed in this FDA 510(k) record. The listed applicant is Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2021-10-08 under 510(k) number K210128. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常见问题

What is the INTEGRA Wound Matrix (Macro-Channels)?

INTEGRA Wound Matrix (Macro-Channels) is a medical device that received FDA 510(k) clearance on 2021-10-08. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K210128.

When did INTEGRA Wound Matrix (Macro-Channels) receive FDA 510(k) clearance?

INTEGRA Wound Matrix (Macro-Channels) received FDA 510(k) clearance on 2021-10-08, under 510(k) number K210128.

Who is the listed applicant for INTEGRA Wound Matrix (Macro-Channels)?

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

What is the FDA product code for INTEGRA Wound Matrix (Macro-Channels)?

The FDA product code for INTEGRA Wound Matrix (Macro-Channels) 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

列明Integra LifeSciences Corporation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。

K251162CUSA® Clarity超声手术吸引器系统K250752AURORA® Surgiscope® 系统（ASX15/60）；AURORA® Surgiscope® 系统（ASX15/80）K240493CUSA® Clarity超声手术吸引器系统K230427CUSA Clarity超声手术吸引器系统K221835CUSA Clarity超声手术吸引器系统K221763CUSA Clarity超声手术吸引器系统

查看所有 28 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 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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