BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge

    K Number: K213135 · Decision Mar 2, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    57
    Applicant Total
    2
    Review Days
    156

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    Basic Information

    Device Name
    Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge
    K Number
    K213135
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chirurgie Innovation
    Date Received
    September 27, 2021
    Decision Date
    March 2, 2022
    Product Code
    FAS
    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
    FAS Electrode, Electrosurgical, Active, Urological

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    Other Clearances by Chirurgie Innovation

    K Number Device Name
    K163090 Plasma Edge System