FDA 510(k)

Myriad Particles

K号: K200502 · 2021-03-31

决定日期2021-03-31

产品代码KGN

决定实质等同

器械摘要

Myriad Particles is the device name listed in this FDA 510(k) record. The listed applicant is Aroa Biosurgery , Ltd.. It received FDA 510(k) clearance on 2021-03-31 under 510(k) number K200502. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常见问题

What is the Myriad Particles?

Myriad Particles is a medical device that received FDA 510(k) clearance on 2021-03-31. The listed applicant is Aroa Biosurgery , Ltd.. The 510(k) number is K200502.

When did Myriad Particles receive FDA 510(k) clearance?

Myriad Particles received FDA 510(k) clearance on 2021-03-31, under 510(k) number K200502.

Who is the listed applicant for Myriad Particles?

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

What is the FDA product code for Myriad Particles?

The FDA product code for Myriad Particles is KGN.

列明Aroa Biosurgery , Ltd.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。

K260669Endoform 皮肤模板 K250598Endoform 重建模板 - PLGA K231305Endoform 牙科膜 K223373Enivo™K200413Symphony K183398Endoform Restella

查看所有 8 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

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。