[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR876.4650]

[Page 365]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES--Table of Contents
 
                       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 Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 63 FR 59228, Nov. 3, 1998]