UV5000W Handle
K-Number: K253226 · 2025-10-23
ApplicantUroviu Corporation
Decision Date2025-10-23
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
UV5000W Handle is a medical device manufactured by Uroviu Corporation. It received FDA 510(k) clearance on 2025-10-23 under approval number K253226. 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 UV5000W Handle?
UV5000W Handle is a medical device that received FDA 510(k) clearance on 2025-10-23. It is manufactured by Uroviu Corporation. The 510(k) number is K253226.
When was UV5000W Handle approved by the FDA?
UV5000W Handle received FDA 510(k) clearance on 2025-10-23, under approval number K253226.
What company makes UV5000W Handle?
UV5000W Handle is manufactured by Uroviu Corporation.
What is the FDA product code for UV5000W Handle?
The FDA product code for UV5000W Handle 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.