[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: 21CFR876.4770]

[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. 876.4770  Urethrotome.

    (a) Identification. A urethrotome is a device that is inserted into 
the urethra and used to cut urethral strictures and enlarge the urethra. 
It is a metal instrument equipped with a dorsal-fin cutting blade which 
can be elevated from its sheath. Some urethrotomes incorporate an 
optical channel for visual control.
    (b) Classification. Class II (performance standards).