[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: 21CFR874.4710]

[Page 346-347]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 874--EAR, NOSE, AND THROAT DEVICES--Table of Contents
 
                       Subpart E--Surgical Devices
 
Sec. 874.4710  Esophagoscope (flexible or rigid) and accessories.

    (a) Identification. An esophagoscope (flexible or rigid) and 
accessories is a tubular endoscopic device with any of a

[[Page 347]]

group of accessory devices which attach to the esophagoscope and is 
intended to examine or treat esophageal malfunction symptoms, esophageal 
or mediastinal disease, or to remove foreign bodies from the esophagus. 
When inserted, the device extends from the area of the hypopharynx to 
the stomach. It is typically used with a fiberoptic light source and 
carrier to provide illumination. The device is made of materials such as 
stainless steel or flexible plastic. This generic type of device 
includes the flexible foreign body claw, flexible biopsy forceps, rigid 
biopsy curette, flexible biopsy brush, rigid biopsy forceps and flexible 
biopsy curette, but excludes the fiberoptic light source and carrier.
    (b) Classification. Class II.