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

    PneumoLiner

    K Number: K192898 · Decision Feb 25, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    3
    Applicant Total
    9
    Review Days
    137

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    Basic Information

    Device Name
    PneumoLiner
    K Number
    K192898
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4050
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Surgical Concepts
    Date Received
    October 11, 2019
    Decision Date
    February 25, 2020
    Product Code
    PMU
    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
    PMU Containment System, Laparoscopic Power Morcellation, With Instrument Port

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