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CIRCON's USA Series™ Laparoscopes are intended for use by qualified physicians to provide access, illumination and visualization of body cavities, hollow organs, and canals during endoscopic and laparoscopic surgical procedures. These include, but are not limited to, laparoscopic procedures used in general surgical procedures, cholecystectomy, colon resection or therapeutic thoracoscopy.

CIRCON's USA Series™ Laparoscopes are substantially equivalent to the other currently marketed laparoscopes which are referenced above. CIRCON's USA Series™ Laparoscopes and their predicate devices are all telescopes that incorporate fiber optics and optical lenses within a rigid shaft and are connected to a light source. Several models of CIRCON's USA Series™ Laparoscopes and predicate devices also incorporate a working channel within the diameter of the rigid shaft that allows for the introduction and manipulation of accessory instrumentation for use during the procedure.

CIRCON ACMI's AEH-3 Electrohydraulic Lithotripter and Probes are intended to be used to fragment stones (calculi) in the urinary and biliary tracts, including the kidney, ureter, bladder, urethra, and common bile duct.

The CIRCON ACMI AEH-3 Electrohydraulic Lithotripter is a bipolar electronic device. When used with its flexible probes, the system is capable of fragmenting calculi so that fragments can be removed without requiring major surgery. In the presence of recommended irrigant solutions, sparks produced by activating the AEH-3 generator produce a series of high amplitude hydraulic shock waves that initiate fragmentation. These shock waves have no adverse effect on tissue because of tissue flexibility, as long as the probe does not come in contact with the tissue surface.