[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: 21CFR876.5160]

[Page 353]
 
                        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. 876.5160  Urological clamp for males.

    (a) Identification. A urological clamp for males is a device used to 
close the urethra of a male to control urinary incontinence or to hold 
anesthetic or radiography contrast media in the urethra temporarily. It 
is an external clamp.
    (b) Classification. Class I (general controls). Except when intended 
for internal use or use on females, the device is exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to Sec. 876.9.

[48 FR 53023, Nov. 23, 1963, as amended at 65 FR 2317, Jan. 14, 2000]