Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)

This device is a family of single-use sphincterotomes (cutting instruments) used during endoscopic procedures to perform papillotomy (cutting of the bile duct opening). The devices come in multiple configurations including preloaded versions with guidewires, standard versions, and triple-lumen versions. They are used with high-frequency electrical current in combination with an endoscope to access and treat biliary ducts.

The subject devices share the same materials, operating principles, and similar dimensional characteristics as the predicate device. Minor dimensional differences exist in guidewire compatibility and knife tip length based on physician preference. Some models offer optional C-Channel and C-Hook features not present in the predicate. The devices are compatible with additional Olympus generators and A-cords introduced since the predicate clearance, verified through electrical safety and EMC testing.

Not stated in this summary.