[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: 21CFR876.4020]

[Page 355]
 
                        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. 876.4020  Fiberoptic light ureteral catheter.


    (a) Identification. A fiberoptic light ureteral catheter is a device 
that consists of a fiberoptic bundle that emits light throughout its 
length and is shaped so that it can be inserted into the ureter to 
enable the path of the ureter to be seen during lower abdominal or 
pelvic surgery.
    (b) Classification. Class II (performance standards).