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510(k) Data Aggregation
K Number
K152848Device Name
AUTOLAP SYSTEM
Manufacturer
M.S.T Medical Surgery Technologies LTD
Date Cleared
2015-11-17
(49 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
M.S.T 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 and 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. The movement of the laparoscope may be controlled as a simple joystick, enabling movements to up/down, left/right, zoom out directions or be guided by the movement of a designated tool within the field of view, enabling movement in oblique trajectories. Additionally, the system enables the surgeon to manually perform larger movements of the laparoscope using the Manual Activation Button affixed to the AutoLap system.
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