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

    CLEANFLOW SYSTEM

    K Number: K910728 · Decision Apr 1, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    13
    Applicant Total
    1
    Review Days
    40

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    Basic Information

    Device Name
    CLEANFLOW SYSTEM
    K Number
    K910728
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4370
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Mitron Technologies, Inc.
    Date Received
    February 20, 1991
    Decision Date
    April 1, 1991
    Product Code
    KQT
    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
    KQT Evacuator, Gastro-Urology

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