Regulation Text
(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 .
Authority
21 U.S.C. 351,360,360c,360e,360j,360l,371.