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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.

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.

This document is a 510(k) summary for a medical device called "Rigid Fiber Optic Laparoscope". It does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth establishment relevant to the request. The document describes the device, its intended use, and compares its technological characteristics to predicate devices for the purpose of demonstrating substantial equivalence for regulatory approval. It does not present data from a study demonstrating the device meets specific performance acceptance criteria.

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