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

    SIGNAL GEAR URETHRAL CATHETER ELECTRODE

    K Number: K113771 · Decision Dec 13, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    84
    Applicant Total
    9
    Review Days
    357

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    Basic Information

    Device Name
    SIGNAL GEAR URETHRAL CATHETER ELECTRODE
    K Number
    K113771
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neurovision Medical Products, Inc.
    Date Received
    December 22, 2011
    Decision Date
    December 13, 2012
    Product Code
    FAP
    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
    FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device

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