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510(k) Data Aggregation

    K Number
    K160171
    Device Name
    Illuminated Mediastinal Access Port
    Manufacturer
    Aegis Surgical Ltd
    Date Cleared
    2016-02-26

    (30 days)

    Product Code
    EWY
    Regulation Number
    874.4720
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aegis Surgical Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Illuminated Mediastinal Access Port is intended to aid the surgeon in direct visualization of the mediastinum and facilitate the introduction and removal of surgical instruments during surgical procedures. The Illuminated Mediastinal Access Port is specifically indicated for use in the anterior, superior and middle mediastinum.
    Device Description
    Illuminated Mediastinal Access Port is a trocar/cannula system used to provide mediastinal surgical access. The device provides open, illuminated surgical access to the mediastinum. The device consists of the following components: Cannula with a working channel, fiber optic bundles, ergonomic handle and blunt tip trocar. The base of the cannula has fiber optic bundles incorporated that may be connected to a standard endoscopic light source. This enhances lighting and visualization within the access device. The device does not include a light source. The ergonomic handle provides a secure grip and ease of maneuverability to the user. The device includes a blunt trocar for dissecting tissue planes. The trocar/cannula access device also includes a handle for connection to a support arm. The handle allows the Mediastinoscope to be held in position so that the surgeon can operate using both hands, without holding or re-positioning the Mediastinoscope and to provide stability for the Mediastinoscope during operation. The entire device is disposable, single use and provided pre-sterilized.
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    K Number
    K141622
    Device Name
    ILLUMINATED MEDIASTINOSCOPE
    Manufacturer
    AEGIS SURGICAL LTD
    Date Cleared
    2015-01-09

    (206 days)

    Product Code
    EWY
    Regulation Number
    874.4720
    Why did this record match?
    Applicant Name (Manufacturer) :

    AEGIS SURGICAL LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Illuminated Mediastinal Access Port is intended to aid the surgeon in direct visualization of the mediastinum and facilitate the introduction and removal of surgical instruments during surgical procedures. The Illuminated Mediastinal Access Port is specifically indicated for use in the anterior, superior and middle mediastinum.
    Device Description
    The Illuminated Mediastinal Access Port is a trocar/cannula system used to provide mediastinal surgical access. The device includes a blunt trocar for dissecting tissue planes. The open cannula provides for direct visualization of the surgical space and includes small notches at the rim to anchor sutures. The base of the cannula has fiber optic bundles incorporated that may be connected to a fiber optic light cable and an endoscopic light source. This enhances lighting and visualization within the access device. The device does not include a light source. The trocar/cannula access device also includes a handle for connection to a support arm. This allows the mediastinoscope to be held in position so that the surgeon can operate using both hands, without holding or re-positioning the mediastinoscope, and to provide stability for the mediastinoscope during operation. The entire device is disposable, single use and is provided pre-sterilized.
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