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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    Advanced Surgical Concepts Ltd.

    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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    K Number
    DEN150028
    Device Name
    PneumoLiner
    Manufacturer
    ADVANCED SURGICAL CONCEPTS LTD.
    Date Cleared
    2016-04-07

    (293 days)

    Product Code
    PMU
    Regulation Number
    884.4050
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED SURGICAL CONCEPTS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PneumoLiner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during single-port or multi-site laparoscopic surgery during power morcellation and removal. The PneumoLiner is compatible with bipolar or electromechanical laparoscopic power morcellators that are between 15 mm and 18 mm in shaft outer diameter and 135 mm and 180 mm 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 PneumoLiner System consists of two main components: - A laparoscopic multi-instrument port - Tissue pouch (PneumoLiner) intended to provide a separately contained space within the abdomen for the safe morcellation of tissue As depicted in Figure 1 below, the laparoscopic multi-instrument port consists of the Retractor, Retractor Introducer and the Boot Assembly.
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