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

    ERCP CANNULA

    K Number: K834414 · Decision Feb 4, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    17
    Applicant Total
    21
    Review Days
    51

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    Basic Information

    Device Name
    ERCP CANNULA
    K Number
    K834414
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Hobbs Medical, Inc.
    Date Received
    December 15, 1983
    Decision Date
    February 4, 1984
    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 Hobbs Medical, Inc.

    K Number Device Name
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    K922396 FUJINON FORCEPS -- MODIFICATION
    K921026 PRESSURE GAUGE
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