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The ClearPath Lower GI is intended to connect to standard colonoscopes to help facilitate intraprocedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces, and other bodily fluids and matter, e.g. blood. It is for use only by trained medical personnel located in hospitals, clinics, and doctors' offices.

The proposed modified ClearPath Lower Gl is one component of the predicate ClearPath (K091305) which included a number of components: Controller, Tubing Set, Irrigation set (now referred to as the ClearPath Lower GI). We are proposing to only modify the ClearPath Lower GI which attaches to a conventional endoscope. The ClearPath Lower GI includes one suction tube + tip, one irrigation tube + tip, and a sleeve to attach to the endoscope. The ClearPath Lower GI is connected to the ClearPath Controller and the ClearPath Tubing (K091305) and allows for irrigation and evacuation of debris from the colon during an endoscopic procedure. The device can accommodate several sizes and configurations of endoscopes with a change in the attachment ring.

The ClearPath Upper Gl is intended for irrigating or cleaning the upper digestive tract and evacuating the irrigation fluid, blood and bile in the upper GI tract during endoscopic procedures. It is for use only by trained medical personnel located in hospitals, clinics, and doctors' offices.

The ClearPath Upper GI includes one suction tube + tip, one irrigation tube + tip, and a sleeve to attach to the endoscope. The ClearPath Upper GI is connected to the ClearPath Controller and the ClearPath Tubing (K091305) and allows for irrigation and evacuation of debris from the upper gastrointenstinal tract during an endoscopic procedure. The device can accommodate several sizes and configurations of endoscopes with a change in the attachment ring.

The ClearJet is an irrigation / biopsy adapter and irrigation tubing set used to cover the opening to the biopsy / suction / irrigation channel of standard endoscopes. It provides access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation. It is for use only by trained medical personnel located in hospitals, clinics, and doctors' offices.

The proposed ClearJet adapter is intended to perform irrigation through the working channel of an endoscope by providing a means to control the fluid irrigation with the cleared ClearPath control unit. The ClearJet's is design to improve procedure reliability by improving visualization during endoscopic procedures. The ClearJet utilizes an irrigation / biopsy valve adapter on doling attachment to an endoscope's working channel port for the purpose of performing a colon or stomach wash. The ClearJet is composed of two major units: - . A disposable Irrigator and - . A Control cabinet It is designed to fit the standard endoscope models of Pentax, Olympus, and Fuijinon.

The ClearPath-UGI System is intended for irrigating or cleaning the upper digestive tract and evacuating the irrigation fluid, blood and bile in the upper GI tract during endoscopic procedures. It is for use only by trained medical personnel located in hospitals, clinics, and doctors' offices.

The ClearPath UGI's main purpose is to improve procedure reliability by improving procedural visualization during endoscopic procedures. The ClearPath UGI utilizes a suction / irrigation head for the purpose of irrigating or cleaning the upper digestive tract. The ClearPath UGI is composed of two major units: . The disposable Irrigator and . the reusable Control cabinet. The disposable Irrigator is attached to a standard endoscope by means of silicone bands and does not hinder the endoscope's functionality nor affects the procedure sequence in any way. The Control cabinet supplies the water flow and vacuum control using a peristaltic pump. The standard medical facility vacuum system is the vacuum source.

The ClearPath is intended to connect to standard colonoscopes to help facilitate intraprocedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water) and feces. It is for use only by trained medical personnel located in hospitals, clinics, and doctors' offices.

The ClearPath's main purpose is to improve procedure reliability and decrease colonoscopy procedures cancellation rate by enabling intra-procedural cleaning of a poorly prepared colon. The ClearPath utilizes a suction / irrigation head for the purpose of irrigating or cleaning the colon and enabling the rapid evacuation of large amounts of water and feces. The ClearPath is composed of two major units: - . The disposable Irrigator and - . the reusable Control cabinet. The disposable Irrigator is attached to a standard colonoscope by means of silicon bands and does not hinder colonoscope functionality nor affects the procedure sequence in any way. The Control cabinet supplies the water flow and vacuum control using a peristaltic pump. The standard medical facility vacuum system is the vacuum source.