DEVICE: LITHOCLAST (07613353123659)

A slender, metal, tubular device that is coaxially attached to an ultrasonic lithotripsy system handpiece [a hand-held acoustic transducer that produces ultrasound (US) waves] and intended to transmit US waves to calculi (stones) in the urinary tract (i.e., kidneys, ureters, and bladder) for their fragmentation. Its distal end is brought into contact with calculi and transmits the energy, breaking down the calculi in the body for removal through its lumen. This device is introduced through the working channel of an appropriate endoscope (e.g., a percutaneous nephroscope for ureteral stones). This is a reusable device intended to be sterilized prior to use.

A slender, rod-like device intended to be used as part of an intracorporeal lithotripsy system to transmit shock waves from electrohydraulic or pneumatic sources directly to a calculus in the urinary tract (i.e., kidneys, ureters, and bladder), providing high-speed fragmentation of the calculus in situ. It is typically made of high-grade stainless steel, may be rigid or semi-flexible, and is available in a variety of sizes and lengths. It may be introduced endoscopically through a natural body orifice or a surgically made opening. This is a reusable device intended to be sterilized prior to use.