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Optical Biopsy Forceps - The intended use is in urological procedures to endoscopically remove tissue for evaluation. Urological Visual Obturators - The intended use is in urological procedures to endoscopically examine and allow access to the urethra and bladder. The obturator is inserted into the sheath and its blunt end protrudes from the distal end. It protects the tissue when the sheath is entered into the area under examination. The visual obturator has a cystoscope directly inserted in the center of the obturators to allow for visualization while entering the subject. Optical Stone Crushing Forceps - The intended use for the optical stone crushing forceps is in urological procedures to endoscopically remove, manipulate, crush, or grasp calculi (i.e. stones) and other foreign objects.

Endoscopes and accessories are described in 21 CFR 8876.1500. The COMEG Endoscopy devices that we intend to market include Optical Biopsy Forceps, Urological Visual Obturators, and Optical Stone Crushing Forceps. The stainless steel of which the devices are fabricated is ASTM type 304 which meets the ASTM specification F899-84 Standards for Stainless Steel Billet, Bar and Wire for Surgical Instruments and is biocompatible with human tissue. The devices can be reused and instructions for cleaning and sterilization will be provided.