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

    DOBBHOFF(R) PAPILLOTOME

    K Number: K896612 · Decision Feb 12, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    180
    Applicant Total
    70
    Review Days
    83

    Basic Information

    Device Name
    DOBBHOFF(R) PAPILLOTOME
    K Number
    K896612
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    BIOSEARCH MEDICAL PRODUCTS, INC.
    Date Received
    November 21, 1989
    Decision Date
    February 12, 1990
    Product Code
    KNS
    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
    KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

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