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FDA 510(k)

Repris Bladder Injection System

K-Number: K180214 · 2018-05-03

ApplicantUro-1, Inc.
Decision Date2018-05-03
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Uro-1, Inc.. The 510(k) number is K180214.

When was Repris Bladder Injection System approved by the FDA?

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

What company makes Repris Bladder Injection System?

Repris Bladder Injection System is manufactured by Uro-1, Inc..

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

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

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Related Devices (Code: FBK)

K153625Single Use Injector NM600/610Olympus Medical Systems Corp. K151475EndoChoice Select Injection NeedleEndochoice, Inc. K172227Endoscopic Injection NeedleCarbon Medical Technologies, Inc. K171602Williams Cystoscopic Injection NeedleCook Incorporated K171454Interject Injection Therapy Needle CatheterBoston Scientific Corporation K181690Clear-Jet Injection CatheterFinemedix Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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