FDA 510(k)

SpaceOAR Vue Hydrogel

K号: K182971 · 2019-07-19

决定日期2019-07-19

产品代码OVB

咨询委员会RA

决定实质等同

器械摘要

SpaceOAR Vue Hydrogel is the device name listed in this FDA 510(k) record. The listed applicant is Augmenix, Inc.. It received FDA 510(k) clearance on 2019-07-19 under 510(k) number K182971. The device is classified under product code OVB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SpaceOAR Vue Hydrogel?

SpaceOAR Vue Hydrogel is a medical device that received FDA 510(k) clearance on 2019-07-19. The listed applicant is Augmenix, Inc.. The 510(k) number is K182971.

When did SpaceOAR Vue Hydrogel receive FDA 510(k) clearance?

SpaceOAR Vue Hydrogel received FDA 510(k) clearance on 2019-07-19, under 510(k) number K182971.

Who is the listed applicant for SpaceOAR Vue Hydrogel?

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

What is the FDA product code for SpaceOAR Vue Hydrogel?

The FDA product code for SpaceOAR Vue Hydrogel is OVB.

列明Augmenix, 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。

K181465SpaceOAR System

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