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510(k) Data Aggregation

    K Number
    K253226
    Device Name
    UV5000W Handle
    Manufacturer
    UroViu Corporation
    Date Cleared
    2025-10-23

    (24 days)

    Product Code
    FAJ
    Regulation Number
    876.1500
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K250797
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The UV5000W 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 UroViu Cannula Uro-G HD, Uro-G, Uro-V, Uro-N, and Hystero-V connect to the UV5000W Handle to become an endoscopic system that is intended to allow visualization of the urethra and bladder or cervical canal and uterine cavity for the purpose of performing diagnostics. This 510(k) discloses the modifications made to the UV5000 Handle (K250797) with the capability of transmitting the images captured wirelessly to an external monitor.

    AI/ML Overview

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