StacksVerified U.S. regulatory reference

21 CFR §876.4650

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (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.
  2. (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.