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510(k) Data Aggregation

    K Number
    K043284
    Device Name
    ENDOASSIST
    Manufacturer
    ARMSTRONG HEALTHCARE LIMITED
    Date Cleared
    2005-02-25

    (91 days)

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

    ARMSTRONG HEALTHCARE LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EndoAssist 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 qastric 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. * In this context "laparoscopic" is taken to embrace the use of a rigid endoscope in any part of the body
    Device Description
    EndoAssist is a head-controlled Endoscopic camera manipulator. It is intended for use in minimally invasive laparoscopic, thoracoscopic, urological, gynecological and cardiac surgery and allows the surgeon directly to control movements of a rigid endoscope by head gestures.
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    K Number
    K041477
    Device Name
    PATHFINDER
    Manufacturer
    ARMSTRONG HEALTHCARE LIMITED
    Date Cleared
    2004-12-09

    (189 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARMSTRONG HEALTHCARE LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Stereotaxic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon manually to guide standard neurosurgical instruments.
    Device Description
    A stereotaxic system with a computer-controlled mechanical arm for spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and utilises CCD camera registration based on fiducial markers. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments.
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