§ 876.5160. Urological clamp.
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/us/cfr/t21/s§ 876.5160·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]