21 C.F.R. § 876.4770 Urethrotome.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 876—GASTROENTEROLOGY-UROLOGY DEVICES
Subpart E—Surgical Devices
§ 876.4770 Urethrotome.
