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510(k) Data Aggregation

    K Number
    K250797
    Device Name
    UV5000 Handle
    Manufacturer
    UroViu Corporation
    Date Cleared
    2025-09-11

    (181 days)

    Product Code
    FAJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K232837
    Predicate For
    K253226
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The UV5000 Handle is to be used with UroViu Cannula Uro-G HD, Uro-G, Uro-V, Uro-N, and Hystero-V and is intended to be used to permit viewing of the urethra and bladder or cervical canal and uterine cavity for the purpose of performing diagnostics.

    Device Description

    The Uro-G Cystoscope System is comprised of a cannula and handle that is intended to allow visualization of the urethra, bladder, cervical canal, and uterine cavity for the purpose of performing diagnostics. This 510(k) discloses the modifications made to the handle of the Uro-G HD Cystoscope System (K232837), UV5000 Handle. The Uro-G HD Flexible Cystoscope System is a handheld, battery-operated portable cystoscope consisting of a disposable steerable endoscopic cannula with a 2.2 mm channel for fluid infusion and instrument advancement, and a reusable handle with a video monitor.

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