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

    SCION BALLOON ELEVATOR

    K Number: K973698 · Decision Mar 31, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    4
    Review Days
    186

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    Basic Information

    Device Name
    SCION BALLOON ELEVATOR
    K Number
    K973698
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Scion International, Inc.
    Date Received
    September 26, 1997
    Decision Date
    March 31, 1998
    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 Scion International, Inc.

    K Number Device Name
    K040087 RABBIT
    K973652 DUOCLIPPER TITANIUM CLIPS
    K963006 SCION SAPHENOUS VEIN HARVESTING SYSTEM