BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    EVA5 Insufflator

    K Number: K230474 · Decision Mar 24, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    23
    Applicant Total
    6
    Review Days
    30

    Basic Information

    Device Name
    EVA5 Insufflator
    K Number
    K230474
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Palliare Ltd.
    Date Received
    February 22, 2023
    Decision Date
    March 24, 2023
    Product Code
    FCX
    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
    FCX Insufflator, Automatic Carbon-Dioxide For Endoscope

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FCX), ordered by most recent decision date.

    MedicCO2LON (MedicCO2LON)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    END 200 Endoscopic Tubeset

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CO2mbiLED

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BAROnova Insufflation System, BAROnova Accessory Kit

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    FUJIFILM Endoscopic CO2 Regulator GW-100

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Nexcore GI Insufflator

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Palliare Ltd.

    K Number Device Name
    K232902 EVA15 insufflator
    K222901 EVA15 insufflator
    K202922 END 200 Endoscopic Tubeset
    K202799 EVA15
    K193520 EVA 15 Insufflator