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

    ENDOSCOPIC CATHETER

    K Number: K953967 · Decision Jan 22, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    17
    Applicant Total
    2
    Review Days
    153

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    Basic Information

    Device Name
    ENDOSCOPIC CATHETER
    K Number
    K953967
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Act Medical, Inc.
    Date Received
    August 22, 1995
    Decision Date
    January 22, 1996
    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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    Other Clearances by Act Medical, Inc.

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