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510(k) Data Aggregation

    K Number
    K090340
    Device Name
    FREEHAND
    Manufacturer
    PROSURGICS LIMITED
    Date Cleared
    2009-05-22

    (101 days)

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

    PROSURGICS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Freehand is indicated for use in general thoracoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy and sinuscopy, where a rigid laparoscope/endoscope is intended for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy hernia repair fundoplication splenectomy appendectomy hemicolectomy sympathectomy lymph node dissection hysterectomy gastric banding gastric by pass nephrectomy radical prostatectomy anterior spinal fusion, decompression fixation wedge resection lung biopsy pleural biopsy, internal mammary artery dissection for coronary artery bypass coronary artery bypass grafting where endoscopic visualization is indicated examination of the evacuated cardiac chamber during performance of valve replacement or repair.
    Device Description
    Freehand is a modification of Prosurgics EndoAssist. The Freehand is intended for use in minimally invasive laparoscopic, thoracoscopic, urological, gynecological and cardiac surgery where a rigid laparoscope/endoscope is intended for use, and allows the surgeon directly to control movements of a rigid endoscope by head movements. Changes that have been made are to provide simpler control mechanisms that should result in greater reliability, as well as several convenience features. From the surgeon's point of view, the two devices are the same as far as their operation and functions are concerned.
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