21 C.F.R. · Food and Drugs
21 C.F.R. § 876.4770

Urethrotome.

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21 C.F.R. § 876.4770 — Urethrotome.

§ 876.4770 Urethrotome. (a) Identification. A urethrotome is a device that is inserted into the urethra and used to cut urethral strictures and enlarge the urethra. It is a metal instrument equipped with a dorsal-fin cutting blade which can be elevated from its sheath. Some urethrotomes incorporate an optical channel for visual control. (b) Classification. Class II (special 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 84 FR 71813, Dec. 30, 2019]

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The regulatory text of 21 C.F.R. § 876.4770 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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