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The Disposable Sphincterotome is indicated for use in transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. This device can also be used to cannulate and inject contrast medium.

The subject device Disposable Sphincterotome is a sterile, single-use endoscopic device, intended to be used with flexible endoscopes for intubation of the pancreaticobiliary system and for sphincterotome. The disposable sphincterotome consists of cutting wire, sheath, quide wire connector, injection connector, conductive column, finger ring, handle, and imaging ring. The subject device has 72 specifications. The differences among these models are the Cutting Length, Tip Length, Working Length and Type of guide wire lumen channel. The subject device is EO sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and placed in a sterility maintenance package to ensure a shelf life of 3 years. The main materials used for construction of Disposable Sphincterotome include PTFE, ABS, SUS304.