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Intended to provide visualization (via a video monitor) and therapeutic access to the lower gastrointestinal tract including, but not limited to the organs, tissues, and subsystems of the large bowel. The device is introduced rectally as with any standard colonoscope, when indications consistent with the requirement for the procedure are observed in adult patient populations.

The ProtectiScope CS, Non-intrapull colonoscope is a software controlled device intended for use to visualize the colon to the level of the cecum. The ProtectiScope CS, Non-intrapull colonoscope includes a system control unit, flexible insertion tube, control body, and umbilicus. The insertion tube features a disposable sleeve that is discarded after the colonoscopy procedure is completed. The ProtectiScope CS, Non-intrapull colonoscope is designed for use in both diagnostic and therapeutic colonoscopy procedures. The insertion tube is designed to accommodate biopsy tools and equipment to remove intestinal polyps and other therapeutic uses. The design change included in this submission is removal of the air assisted push technology feature of the device. The modified Protectiscope CS, Non-Intrapull device is manually advanced through the large bowel for visualization of the colon.