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

    E.R.C.P. CANNULAS

    K Number: K820431 · Decision Apr 9, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    17
    Applicant Total
    19
    Review Days
    51

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    Basic Information

    Device Name
    E.R.C.P. CANNULAS
    K Number
    K820431
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    American Endoscopy, Inc.
    Date Received
    February 17, 1982
    Decision Date
    April 9, 1982
    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 American Endoscopy, Inc.

    K Number Device Name
    K853274 AMERICAN DILATATION SYSTEM
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    K833491 ENDO BITE BLOCK
    K840818 BIOPSY FORCEPS
    K833859 TAMPONADE BALLOON CUFF
    K833492 PERCUTANEOUS ENDOSCOPIC GASTROSCOPY
    K832458 AUTOMATIC ENDOSCOPE
    K821818 RETRIEVAL BALLOONS
    K821819 PIGTAIL STENTS
    K822062 BALL TIP COAGULATING ELECTRODES
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