BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    AUTO-BAND LIGATOR

    K Number: K081142 · Decision May 16, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    14
    Applicant Total
    2
    Review Days
    24

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    Basic Information

    Device Name
    AUTO-BAND LIGATOR
    K Number
    K081142
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.4400
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Scandimed International
    Date Received
    April 22, 2008
    Decision Date
    May 16, 2008
    Product Code
    MND
    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
    MND Ligator, Esophageal

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    Other Clearances by Scandimed International

    K Number Device Name
    K083556 MODIFICATION TO AUTO-BAND LIGATOR