21 C.F.R. § 876.5365 Esophageal dilator.
Title 21 - Food and Drugs
(a) Identification. An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive). (b) Classification. Class II (performance standards).
Title 21: Food and Drugs
PART 876—GASTROENTEROLOGY-UROLOGY DEVICES
Subpart F—Therapeutic Devices
§ 876.5365 Esophageal dilator.
