BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box

    K Number: K223926 · Decision Oct 6, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    91
    Applicant Total
    7
    Review Days
    280

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    Basic Information

    Device Name
    VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box
    K Number
    K223926
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medimaging Integrated Solution, Inc (Miis)
    Date Received
    December 30, 2022
    Decision Date
    October 6, 2023
    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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