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These instruments (sphincterotomes and guidewires) have been designed to be used with an Olympus endoscope for papillotomy using high-frequency current. The preloaded guidewire is used for guiding and exchanging endoscopic accessories for billary duct, including but not limited to the common bile, cystic, pancreatic and right and left hepatic ducts.

The subject devices consist of the papillotomy knife for endoscopic sphincterotomy. The predicate device consists of a closed quidewire lumen, and the subject devices consist of a partially open quidewire lumen. The partially open guidewire lumen is called the C-Channel design, and the exchange operation of the quidewire is added. The subject Single Use Preloaded Sphincterotome V(Distal Wireguided) has a preloaded guidewire, and the subject Single Use Sphincterotome V(Distal Wireguided) does not have a preloaded guidewire. The preloaded guidewire of the subject device is a minor modification of the product from Terumo Corporation that has been cleared via premarket notification, K091417.