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

    AUTO-BAND LIGATOR

    K Number: K031236 · Decision Nov 14, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    14
    Applicant Total
    2
    Review Days
    210

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    Basic Information

    Device Name
    AUTO-BAND LIGATOR
    K Number
    K031236
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4400
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Scandimed. A.S.
    Date Received
    April 18, 2003
    Decision Date
    November 14, 2003
    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. A.S.

    K Number Device Name
    K031238 VARICES NEEDLE