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510(k) Data Aggregation

    K Number
    K131375
    Device Name
    AUTOLAP SYSTEM
    Manufacturer
    MST - MEDICAL SURGERY TECHNOLOGIES LTD.
    Date Cleared
    2013-09-19

    (129 days)

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

    MST - MEDICAL SURGERY TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AutoLap System is indicated for General laparoscopic, Gynecologic and Urologic procedures for the purpose of holding and controlling the movement of a standard laparoscope or rigid endoscope within surgical cavities during minimally invasive laparoscopic surgery.
    Device Description
    The AutoLap System is designed to hold and control the movement of a laparoscope or rigid endoscope during laparoscopic procedures. The AutoLap System includes both software and hardware. Hardware components include a Processing Unit, which includes the system's electronics and software algorithms, a Base Unit and a Laparoscopic Unit that include motors and sensors. The Base Unit is mounted on the operating bed. An accessory cart that is used for placing the system's components during the procedure and their storage afterwards is also provided. To maneuver the laparoscope to the desired position, the surgeon presses a single button, referred to as Command Unit, which is affixed to his/her hand or to the surgical instrument and transmits RF signals to the system. Additionally, the system enables the surgeon to manually perform larger movements of the laparoscope using the Manual Activation Button affixed to the AutoLap system. Movements can be performed in the left/right, up/down and zoom in/ zoom out directions.
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