[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: 21CFR876.4480]

[Page 364]
 
                        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. 876.4480  Electrohydraulic lithotriptor.

    (a) Identification. An electrohydraulic lithotriptor is an AC-
powered device used to fragment urinary bladder stones. It consists of a 
high voltage source connected by a cable to a bipolar electrode that is 
introduced into the urinary bladder through a cystoscope. The electrode 
is held against the stone in a water-filled bladder and repeated 
electrical discharges between the two poles of the electrode cause 
electrohydraulic shock waves which disintegrate the stone.
    (b) Classification. Class II. The special control for this device is 
FDA's ``Guidance for the Content of Premarket Notifications for 
Intracorporeal Lithotripters.''

[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 65 
FR 17145, Mar. 31, 2000]