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510(k) Data Aggregation

    K Number
    K100346
    Device Name
    ENDOCLEAR SYSTEM
    Manufacturer
    VIRTUAL PORTS LTD
    Date Cleared
    2010-03-10

    (26 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIRTUAL PORTS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EndoClear™ Laparoscopes Accessory is intended to be used by qualified physicians to provide endoscope lens cleaning for uninterrupted visualization of internal structures in a wide variety of diagnostic and therapeutic laparoscopic procedures.
    Device Description
    The Virtual Ports EndoClear™ system is an accessory tool for laparoscopic procedures that consists of the EndoClear™ Lens Cleaner and the Virtual Ports Applier. The EndoClear™ Lens Cleaner is an internally anchored, hands-free, laparoscope lens cleaning device that is attached to the internal operating cavity wall and remains in position until completion of the surgery, enabling the surgeon to effectively clean the laparoscope lens of blood, fat, fog, and secretions without removing it from the cavity. The EndoClear™ Lens Cleaner is introduced via a cannula using the Virtual Ports Applier, which introduces the EndoClear™ Sens Cleaner into the cavity, enables positioning of the device under endoscopic guidance, anchors it to the internal cavity wall, and removes the EndoClear™ Lens Cleaner at the end of the surgical procedure.
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    K Number
    K080051
    Device Name
    VIRTUAL PORTS ENDOCLEAR SYSTEM
    Manufacturer
    VIRTUAL PORTS LTD
    Date Cleared
    2008-03-21

    (73 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIRTUAL PORTS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EndoClear™ Laparoscopes Accessory is intended to be used by qualified physicians to provide endoscope lens cleaning for uninterrupted visualization of internal structures in a wide variety of diagnostic and therapeutic laparoscopic procedures.
    Device Description
    The Virtual Ports EndoClear™ system is a sterile, single patient use system consisting of: EndoClear™ Lens Cleaner and the EndoClear™ Introducer. The EndoClear Lens Cleaner is an internally anchored hands-free, laparoscope lens cleaning device which is attached to the internal abdominal cavity wall and remains in position until completion of the surgery, enabling the surgeon to effectively clean the lens of blood, fat, fog, and secretions without removing it from the cavity. The Virtual Ports EndoClear™ Lens Cleaner is introduced via a cannula using the EndoClear™ Introducer, which also removes the EndoClear™ Lens Cleaner at the end of the surgical procedure.
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