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510(k) Data Aggregation

    K Number
    DEN170075
    Device Name
    ContainOR
    Manufacturer
    Advanced Surgical Concepts Ltd.
    Date Cleared
    2017-12-19

    (81 days)

    Product Code
    PZQ
    Regulation Number
    878.4825
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    Product Code :

    PZQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ContainOR is a bag containment system intended for use by qualified surgeons for tissue extraction and/or power morcellation during general laparoscopic procedures. The ContainOR is compatible with bipolar or electromechanical laparoscopic power morcellators that are between 15mm and 18mm in shaft outer diameter and 135mm and 180mm in shaft working length and which have an external component that allows for the proper orientation of the laparoscope to perform a contained morcellation.
    Device Description
    The ContainOR device consists of two main components: - A laparoscopic multi-instrument port . - Tissue pouch (Bag) intended to provide a contained space in the abdomen for the safe morcellation of tissue.
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