§ 876.4500. Mechanical lithotriptor.
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/us/cfr/t21/s§ 876.4500·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]