BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇮🇪 Ireland

    ContainOR

    K Number: DEN170075 · Decision Dec 19, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    81

    Basic Information

    Device Name
    ContainOR
    K Number
    DEN170075
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    878.4825
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Applicant
    Advanced Surgical Concepts Ltd.
    Date Received
    September 29, 2017
    Decision Date
    December 19, 2017
    Product Code
    PZQ
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PZQ General Laparoscopic Power Morcellation Containment System