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510(k) Data Aggregation
K Number
K043284Device Name
ENDOASSIST
Manufacturer
ARMSTRONG HEALTHCARE LIMITED
Date Cleared
2005-02-25
(91 days)
Product Code
GCJ
Regulation Number
876.1500Why 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
K041477Device Name
PATHFINDER
Manufacturer
ARMSTRONG HEALTHCARE LIMITED
Date Cleared
2004-12-09
(189 days)
Product Code
HAW
Regulation Number
882.4560Why 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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