Uro-N Cystoscope
K-Number: K182876 · 2019-07-02
ApplicantUroviu Corporation
Decision Date2019-07-02
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Uro-N Cystoscope is a medical device manufactured by Uroviu Corporation. It received FDA 510(k) clearance on 2019-07-02 under approval number K182876. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Uro-N Cystoscope?
Uro-N Cystoscope is a medical device that received FDA 510(k) clearance on 2019-07-02. It is manufactured by Uroviu Corporation. The 510(k) number is K182876.
When was Uro-N Cystoscope approved by the FDA?
Uro-N Cystoscope received FDA 510(k) clearance on 2019-07-02, under approval number K182876.
What company makes Uro-N Cystoscope?
Uro-N Cystoscope is manufactured by Uroviu Corporation.
What is the FDA product code for Uro-N Cystoscope?
The FDA product code for Uro-N Cystoscope is FAJ.
Other Devices by Uroviu Corporation
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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.