[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR876.4590]

[Page 351]
 
                        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. 876.4590  Interlocking urethral sound.

    (a) Identification. An interlocking urethral sound is a device that 
consists of two metal sounds (elongated instruments for exploring or 
sounding body cavities) with interlocking ends, such as with male and 
female threads or a rounded point and mating socket, used in the repair 
of a ruptured urethra. The device may include a protective cap to fit 
over the metal threads.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996]