21 C.F.R. § 876.4650 Water jet renal stone dislodger system.
Title 21 - Food and Drugs
(a) Identification. A water jet renal stone dislodger system is a device used to dislodge stones from renal calyces (recesses of the pelvis of the kidney) by means of a pressurized stream of water through a conduit. The device is used in the surgical removal of kidney stones. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §876.9. [48 FR 53023, Nov. 23, 1983, as amended at 63 FR 59228, Nov. 3, 1998]
Title 21: Food and Drugs
PART 876—GASTROENTEROLOGY-UROLOGY DEVICES
Subpart E—Surgical Devices
§ 876.4650 Water jet renal stone dislodger system.
