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510(k) Data Aggregation
K Number
K971455Device Name
CLARUS MODEL 5197 SIGHTLITE
Manufacturer
CLARUS MEDICAL SYSTEMS, INC.
Date Cleared
1997-05-20
(29 days)
Product Code
FTI
Regulation Number
876.1500Why did this record match?
Product Code :
FTI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Clarus Model 5197 SightLite is intended as a illumination source for endoscopes. These endoscopes would be legally marketed Clarus Medical Systems devices. The SightLite is intended for multiple use. It is sold non-sterile.
Device Description
The Clarus Model 5197 SightLite is a hand held illumination device for endoscopy. The device has a means of attaching a legally marketed optical assembly manufactured by Clarus Medical Systems that is sold separately. The image connector on the endoscope attaches to the optical assembly. The male illumination receptacle on the endoscope attaches to the female receptacle on the Model 5197 SightLite. The power source is four 1.5 volt AA lithium batteries. The illumination source is a Tungsten Halogen lamp.
The SightLite is intended for multiple use. It is sealed for cleaning and disinfecting.
The optical assembly used with the SightLite endoscopic light source is a separate, legally marketed, Clarus Medical Systems device that can be attached to the SightLite by means of a machined clasp that is an intrical part of the SightLite.
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