Uro-V Cystoscope
K-Number: K171500 · 2018-01-30
ApplicantUroviu Corporation
Decision Date2018-01-30
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Uro-V Cystoscope is a medical device manufactured by Uroviu Corporation. It received FDA 510(k) clearance on 2018-01-30 under approval number K171500. 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-V Cystoscope?
Uro-V Cystoscope is a medical device that received FDA 510(k) clearance on 2018-01-30. It is manufactured by Uroviu Corporation. The 510(k) number is K171500.
When was Uro-V Cystoscope approved by the FDA?
Uro-V Cystoscope received FDA 510(k) clearance on 2018-01-30, under approval number K171500.
What company makes Uro-V Cystoscope?
Uro-V Cystoscope is manufactured by Uroviu Corporation.
What is the FDA product code for Uro-V Cystoscope?
The FDA product code for Uro-V 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.