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

    DISPOSABLE BENDING CANNULA PR-233Q

    K Number: K011149 · Decision May 15, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    17
    Applicant Total
    22
    Review Days
    29

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    Basic Information

    Device Name
    DISPOSABLE BENDING CANNULA PR-233Q
    K Number
    K011149
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Olympus Optical Co.
    Date Received
    April 16, 2001
    Decision Date
    May 15, 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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