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

    OLYMPUS HX-20 SERIES LIGATING DEVICE

    K Number: K984255 · Decision Jan 12, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    14
    Applicant Total
    2
    Review Days
    43

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    Basic Information

    Device Name
    OLYMPUS HX-20 SERIES LIGATING DEVICE
    K Number
    K984255
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4400
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Olympus Corp of America
    Date Received
    November 30, 1998
    Decision Date
    January 12, 1999
    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 Olympus Corp of America

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