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510(k) Data Aggregation
K Number
K962246Device Name
RIGID FIBER OPTIC LAPAROSCOPE
Manufacturer
Date Cleared
1997-02-07
(241 days)
Product Code
Regulation Number
884.1720Why did this record match?
Applicant Name (Manufacturer) :
HEALTH CARE INTERNATIONAL ASSOC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Saber's Rigid Fiber Optic Laparoscopes are used to permit direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures.
Device Description
Saber Endoscopy's Rigid Fiber Optic Laparoscopes are small diameter endoscopes which consist of fiber optic imaging fibers and illumination fibers contained within a stainless steel jacket. Light from a high intensity light source is transmitted to the scope by a detachable light carrying cable. The light is then carried by the illumination fibers to the target. A distal lens focuses an image of the target onto the image fiber bundle. The image is transmitted to the proximal end of the scope, where it is magnified and focused by an optical eyepiece. The image may be viewed directly through the eyepiece, or the scope may be connected to a video system via a standard endoscopic video coupler.
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