(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]