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

    EVA15 insufflator

    K Number: K222901 · Decision Jan 27, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    141
    Registration Numbers
    141
    Same Product Code
    176
    Applicant Total
    6
    Review Days
    126

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    Basic Information

    Device Name
    EVA15 insufflator
    K Number
    K222901
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1730
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Palliare , Ltd.
    Date Received
    September 23, 2022
    Decision Date
    January 27, 2023
    Product Code
    HIF
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HIF Insufflator, Laparoscopic

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    Other Clearances by Palliare , Ltd.

    K Number Device Name
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    K193520 EVA 15 Insufflator