[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: 21CFR876.5520]

[Page 361]
 
                        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 F--Therapeutic Devices
 
Sec. 876.5520  Urethral dilator.

    (a) Identification. A urethral dilator is a device that consists of 
a slender hollow or solid instrument made of metal, plastic, or other 
suitable material in a cylindrical form and in a range of sizes and 
flexibilities. The device may include a mechanism to expand the portion 
of the device in the urethra and indicate the degree of expansion on a 
dial. It is used to dilate the urethra. This generic type of device 
includes the mechanical urethral dilator, urological bougies, metal or 
plastic urethral sound, urethrometer, filiform, and filiform follower.
    (b) Classification. (1) Class II (performance standards).
    (2) Class I for the urethrometer, urological bougie, filiform and 
filiform follower, and metal or plastic urethral sound. The devices 
subject to this paragraph (b)(2) are exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter subject 
to the limitations in Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 66 
FR 38802, July 25, 2001]