FDA 510(k)

Repris 膀胱注射系统

K号: K180214 · 2018-05-03

决定日期2018-05-03

产品代码FBK

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决定实质等同

器械摘要

Repris Bladder Injection System is the device name listed in this FDA 510(k) record. The listed applicant is Uro-1, Inc.. It received FDA 510(k) clearance on 2018-05-03 under 510(k) number K180214. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Repris Bladder Injection System?

Repris Bladder Injection System is a medical device that received FDA 510(k) clearance on 2018-05-03. The listed applicant is Uro-1, Inc.. The 510(k) number is K180214.

When did Repris Bladder Injection System receive FDA 510(k) clearance?

Repris Bladder Injection System received FDA 510(k) clearance on 2018-05-03, under 510(k) number K180214.

Who is the listed applicant for Repris Bladder Injection System?

The FDA 510(k) record lists Uro-1, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Repris Bladder Injection System?

The FDA product code for Repris Bladder Injection System is FBK.

列明Uro-1, Inc.为申报人的其他记录

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相关器械（代码：FBK）

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官方来源

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