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

    CytoSure Urinary Access System

    K Number: K142194 · Decision Dec 19, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    91
    Applicant Total
    1
    Review Days
    130

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    Basic Information

    Device Name
    CytoSure Urinary Access System
    K Number
    K142194
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Emmy Medical
    Date Received
    August 11, 2014
    Decision Date
    December 19, 2014
    Product Code
    FAJ
    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
    FAJ Cystoscope And Accessories, Flexible/Rigid

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