CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR876.4650]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 876 -- GASTROENTEROLOGY-UROLOGY DEVICES

Subpart E - Surgical Devices

Sec. 876.4650 Water jet renal stone dislodger system.

(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]