21 CFR § 876.4650
Water jet renal stone dislodger system
June 25, 2020
(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]
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