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

    MODEL #27224P CONTINUOUS FLOW PUMP

    K Number: K832009 · Decision Jul 18, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    92
    Applicant Total
    334
    Review Days
    25

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    Basic Information

    Device Name
    MODEL #27224P CONTINUOUS FLOW PUMP
    K Number
    K832009
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    KARL STORZ Endoscopy-America, Inc.
    Date Received
    June 23, 1983
    Decision Date
    July 18, 1983
    Product Code
    OCX
    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
    OCX Endoscopic Irrigation/Suction System

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