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

    ALIEN RX MICRO CANNULA, MODEL 4530

    K Number: K010993 · Decision Apr 30, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    17
    Applicant Total
    432
    Review Days
    27

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    Basic Information

    Device Name
    ALIEN RX MICRO CANNULA, MODEL 4530
    K Number
    K010993
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Scientific Corp
    Date Received
    April 3, 2001
    Decision Date
    April 30, 2001
    Product Code
    ODD
    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
    ODD Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula

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