Uro-G HD Cystoscope (1520)
K-Number: K243196 · 2024-12-13
ApplicantUroviu Corporation
Decision Date2024-12-13
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Uro-G HD Cystoscope (1520) is a medical device manufactured by Uroviu Corporation. It received FDA 510(k) clearance on 2024-12-13 under approval number K243196. 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-G HD Cystoscope (1520)?
Uro-G HD Cystoscope (1520) is a medical device that received FDA 510(k) clearance on 2024-12-13. It is manufactured by Uroviu Corporation. The 510(k) number is K243196.
When was Uro-G HD Cystoscope (1520) approved by the FDA?
Uro-G HD Cystoscope (1520) received FDA 510(k) clearance on 2024-12-13, under approval number K243196.
What company makes Uro-G HD Cystoscope (1520)?
Uro-G HD Cystoscope (1520) is manufactured by Uroviu Corporation.
What is the FDA product code for Uro-G HD Cystoscope (1520)?
The FDA product code for Uro-G HD Cystoscope (1520) is FAJ.
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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.