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

    8mm Monopolar Curved Scissors (470179)

    K Number: K242610 · Decision Mar 11, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    189

    Basic Information

    Device Name
    8mm Monopolar Curved Scissors (470179)
    K Number
    K242610
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Iconocare Health
    Date Received
    September 3, 2024
    Decision Date
    March 11, 2025
    Product Code
    QSM
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QSM System, Surgical, Computer Controlled Instrument, Remanufactured

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    Other Clearances by Iconocare Health

    K Number Device Name
    K210478 8mm Monopolar Curved Scissors