§ 876.4590. Interlocking urethral sound.
113 words·~1 min read·
/us/cfr/t21/s§ 876.4590·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. An interlocking urethral sound is a device that consists of two metal sounds (elongated instruments for exploring or sounding body cavities) with interlocking ends, such as with male and female threads or a rounded point and mating socket, used in the repair of a ruptured urethra. The device may include a protective cap to fit over the metal threads.
(b)Classification. Class I (general controls). 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, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 66 FR 38801, July 25, 2001]