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

    MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM

    K Number: K895643 · Decision Oct 17, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    10
    Applicant Total
    8
    Review Days
    50

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    Basic Information

    Device Name
    MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM
    K Number
    K895643
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Orthoconcept, Inc.
    Date Received
    August 28, 1989
    Decision Date
    October 17, 1989
    Product Code
    FDC
    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
    FDC Resectoscope, Working Element

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