UV5000 Handle
K-Number: K250797 · 2025-09-11
ApplicantUroviu Corporation
Decision Date2025-09-11
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
UV5000 Handle is a medical device manufactured by Uroviu Corporation. It received FDA 510(k) clearance on 2025-09-11 under approval number K250797. 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 UV5000 Handle?
UV5000 Handle is a medical device that received FDA 510(k) clearance on 2025-09-11. It is manufactured by Uroviu Corporation. The 510(k) number is K250797.
When was UV5000 Handle approved by the FDA?
UV5000 Handle received FDA 510(k) clearance on 2025-09-11, under approval number K250797.
What company makes UV5000 Handle?
UV5000 Handle is manufactured by Uroviu Corporation.
What is the FDA product code for UV5000 Handle?
The FDA product code for UV5000 Handle is FAJ.
Other Devices by Uroviu Corporation
Related Devices (Code: FAJ)
K160766Ambu USR, Ambu MAmbu A/S
K170862Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree CystoscopeSolace Therapeutics, Inc.
K171336Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope SheathHenke-Sass, Wolf GmbH
K181909Luminelle DTx Hysteroscopy SystemUvision360, Inc.
K171500Uro-V CystoscopeUroviu Corporation
K191357Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc.
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.