BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    RedEx

    K Number: K211234 · Decision Sep 17, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    3
    Review Days
    147

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    Basic Information

    Device Name
    RedEx
    K Number
    K211234
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Surgical Concepts, Ltd.
    Date Received
    April 23, 2021
    Decision Date
    September 17, 2021
    Product Code
    GCJ
    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
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Advanced Surgical Concepts, Ltd.

    K Number Device Name
    DEN170075 ContainOR
    DEN150028 PneumoLiner