BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    in2 Smart (in2S)

    K Number: K252809 · Decision Apr 6, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    215

    Basic Information

    Device Name
    in2 Smart (in2S)
    K Number
    K252809
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5026
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Virility Medical , Ltd.
    Date Received
    September 3, 2025
    Decision Date
    April 6, 2026
    Product Code
    QRC
    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
    QRC Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation

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