[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR876.5365]

[Page 361]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES--Table of Contents
 
                     Subpart F--Therapeutic Devices
 
Sec. 876.5365  Esophageal dilator.

    (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).