Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 876  /  Sec. 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 (performance standards).