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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 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.

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. 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.

Other records listing Uro-1, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: FBK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260262Injection NeedleMirco-Tech (Nanjing) Co., Ltd.K253598InjecSURE Injection SystemCarbon Medical Technologies, Inc.K252021Disposable Endoscopic Injection NeedlesChangzhou New Med Micro-Medtech Co., Ltd.K252247Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)Olympus Medical Systems CorporationK241595EzVu Visual Vasopressor injector (EV-19)Veol Medical Technologies Pvt , Ltd.K240675Endoscopic Injection NeedlesPromisemed Hangzhou Meditech Co., Ltd.

Official Source

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

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