21 C.F.R. § 876.4500 Mechanical lithotriptor.
Title 21 - Food and Drugs
(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 (performance standards).
Title 21: Food and Drugs
PART 876—GASTROENTEROLOGY-UROLOGY DEVICES
Subpart E—Surgical Devices
§ 876.4500 Mechanical lithotriptor.
