Section 876.4500 - Mechanical lithotriptor(a)Identification. A mechanical lithotriptor is a device with steel jaws that is inserted into the urinary bladder through the urethra to grasp and crush bladder stones.(b)Classification. Class II (special controls). The device, when it is a biliary mechanical lithotripter, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9 .48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71813 , Dec. 30, 2019