Section 876.5160 - Urological clamp(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, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9 .48 FR 53023, Nov. 23, 1963, as amended at 65 FR 2317 , Jan. 14, 2000; 84 FR 71814 , Dec. 30, 2019