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The intended use for these Semi-Rigid ureteroscopes is for examination/operation of the urinary tract and, using additional accessories, to perform various diagnostic and therapeutic procedures. ACMI Circon's Semi-Rigid Ureteroscopes are intended for use by qualified physicians to provide access to the urinary tract to perform various diagnostic and therapeutic procedures.

ACMI Circon's Semi-Rigid Ureteroscopes are substantially equivalent to other currently marketed ureteroscopes, referenced above. The Semi-Rigid Ureteroscopes and their predicate device(s) are all telescopes that incorporate fiber optical lenses and working channels within a semirigid shaft. The working channels of the Semi-Rigid Ureteroscopes and predicate device(s) allow the insertion of accessory instrumentation during urinary tract procedures. Both the Semi-Rigid Ureteroscopes and the predicate device(s) may be connected to an external light source to permit better illumination of the bladder surfaces.

The DOLPHIN® II Fluid Management System provides low viscosity liquid distension of the uterus for hysteroscopy, and monitors intrauterine pressure, fluid use and fluid deficit.

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The intended use for these Ureteroscopes is for examination/operation of the urinary tract and, using additional accessories, to perform various diagnostic and therapeutic procedures.

Circon ™ MR Series Ureteroscopes

The intended use for the AUR-735 Flexible Pediatric Cystoureteroscope is to examine the urinary tract of pediatric patients, and with the use of additional accessories, perform various diagnostic and therapeutic procedures on pediatric patients.

USA Series™ AUR™ 735 Flexible Pediatric Cystoureteroscope

The CIRCON ACMI USA Series™ APN-2 Flexible Choledochoscope may be used in the biliary tract for diagnostic and therapeutic treatment of ductal stones during laparoscopic cholecystectomy.

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The intended use for this device is for therapeutic and diagnostic procedures in the entire intrarenal collecting system. These devices are marketed as reusable devices. The methods for cleaning, disinfection, and sterilization are presented in "Sterility Information," Section 5 of this document.

Flexible Ureteropyeloscope

The intended use for the Metal Halide Light Sources is to provide optimized light for viewing procedures carried out with flexible and rigid endoscopes.

Metal Halide Light Sources Models, MV-9088-T and MV-9088

The intended use for the Circon Lowsley™ Suprapubic Tractor is for conventional Open Perineal Prostatectomy Procedures and for Suprapubic Catheter Placement.

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The Circon AEH-4 Electrohydraulic Lithotripter (EHL) Probes are to be used with the Circon AEH-4 Electrohydraulic Lithotripter to fragment stones (calculi) in the urinary and biliary tracts.

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The Circon Endotek OM-4 Urodynamics Monitoring System is indicated for urodynamic diagnostic procedures only. It is to be operated only be qualified physicians or qualified personnel under the direction and supervision of a physician trained in urodynamic monitoring techniques. The Circon Endotek OM-4 H2O Cystometry Pump is used to pressurize the filling media during water cystometry diagnostic procedures. The device is designed to be used with the Circon Endotek OM-4 Urodynamic Monitoring System.

The Circon Endotek OM-4 H2O Cystometry Pump is a peristallic pump used with the The Olicon Endotek OM-4 Urodynamic Monitoring System for pressurizing the filling media during cystometry measurements.