BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    UV5000W Handle

    K Number: K253226 · Decision Oct 23, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    91
    Applicant Total
    7
    Review Days
    24

    Basic Information

    Device Name
    UV5000W Handle
    K Number
    K253226
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Uroviu Corporation
    Date Received
    September 29, 2025
    Decision Date
    October 23, 2025
    Product Code
    FAJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FAJ Cystoscope And Accessories, Flexible/Rigid

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    Other Clearances by Uroviu Corporation

    K Number Device Name
    K250797 UV5000 Handle
    K243196 Uro-G HD Cystoscope (1520)
    K232837 Uro-G HD Flexible Cystoscope
    K202921 Uro-G Cystoscope
    K182876 Uro-N Cystoscope
    K171500 Uro-V Cystoscope