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510(k) Data Aggregation
K Number
K070622Device Name
NEOGUIDE ENDOSCOPY SYSTEM
Manufacturer
NEOGUIDE SYSTEMS, INC.
Date Cleared
2007-08-14
(161 days)
Product Code
FDF
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
NEOGUIDE SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NeoGuide Endoscopy System is intended to provide visualization and diagnostic / therapeutic access to the adult lower gastrointestinal tract (including, but not limited to, the anus, rectum, sigmoid colon, colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery.
Device Description
The NeoGuide colonoscope is manually inserted and withdrawn by the physician, who steers and controls it using the electromechanical controls located at the handle. The colonoscope distal tip is equipped with a CCD camera and fiber optic illumination bundles for procedural illumination and includes a standard tool channel for therapeutic procedures. Valves control insuflation air, water irrigation, and suction. The NeoGuide Colonoscope incorporates fifteen active electro-mechanically controlled segments, not including the tip. During a procedure, the segments shape conforms to the path defined by the physician as the tip is manually steered but electromechanically controlled through the colon lumen. Each of the active segments uses four control cables to articulate in the up/down and left/right directions. This mechanism of action is the same as the mechanism used in conventional colonoscope steerable tips. The NeoGuide Endoscopy System displays a graphical representation of the system interpretation of the tip movements commanded by the physician and the depth of insertion of the colonoscope into the patient.
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K Number
K052930Device Name
NAVIGATOR ENDOSCOPY SYSTEM
Manufacturer
NEOGUIDE SYSTEMS, INC.
Date Cleared
2006-01-31
(104 days)
Product Code
FDF
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
NEOGUIDE SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NeoGuide Endoscopy System is intended to provide visualization and diagnostic / therapeutic access to the adult lower gastrointestinal tract (including, but not limited to, the anus, rectum, sigmoid colon, colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery.
Device Description
The NeoGuide Endoscopy System has many features in common with currently marketed colonoscopes. The colonoscope is manually inserted and withdrawn by the physicial, who manually steers and controls it using up/down and left/right steering control knobs on a handle. The colonoscope distal tip is equipped with a CCD camera and fiber optic illumination bundles for procedural illumination. A standard tool channel is incorporated for therapeutic procedures, as well as valves to control insuflation air, water irrigation, and suction.
The NeoGuide Colonoscope differs from currently marketed colonoscopes in that it incorporates fifteen active electro-mechanically controlled segments designed to allow the shape of the insertion tube to conform to the path defined by the physician as the colonoscope tip is manually steered through the colon lumen. The active segments are similar to conventional colonoscope steerable tips, as they each employ four control cables to articulate in the up/down and left/right directions. In order to determine the path selected by the physician during a procedure, the NeoGuide endoscopy system incorporates transducers that measure the angle of articulation of the steerable tip and the depth of insertion of the colonoscope into the patient. Software is required to create an anatomical map and interpret, monitor, and control the insertion tube segments.
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