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

    8mm Monopolar Curved Scissors

    K Number: K210478 · Decision Sep 30, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    588

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    Basic Information

    Device Name
    8mm Monopolar Curved Scissors
    K Number
    K210478
    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
    February 19, 2021
    Decision Date
    September 30, 2022
    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
    K242610 8mm Monopolar Curved Scissors (470179)