[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR876.4680]

[Page 357]
 
                        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. 876.4680  Ureteral stone dislodger.

    (a) Identification. A ureteral stone dislodger is a device that 
consists of a bougie or a catheter with an expandable wire basket near 
the tip, a special flexible tip, or other special construction. It is 
inserted through a cystoscope and used to entrap and remove stones from 
the ureter. This generic type of device includes the metal basket and 
the flexible ureteral stone dislodger.
    (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]