Title 21

SECTION 876.5160

876.5160 Urological clamp.

§ 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]