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

    BARD PROFORMA AND APOLLO PRE-CURVED PAPILLOTOMES

    K Number: K982557 · Decision Sep 10, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    187
    Applicant Total
    2
    Review Days
    50

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    Basic Information

    Device Name
    BARD PROFORMA AND APOLLO PRE-CURVED PAPILLOTOMES
    K Number
    K982557
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bard Interventional Products Div.
    Date Received
    July 22, 1998
    Decision Date
    September 10, 1998
    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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    Other Clearances by Bard Interventional Products Div.

    K Number Device Name
    K963484 BARD HIGH FLOW PAPILLOTOME