[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: 21CFR874.4680]

[Page 346]
 
                        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. 874.4680  Bronchoscope (flexible or rigid) and accessories.

    (a) Identification. A bronchoscope (flexible or rigid) and 
accessories is a tubular endoscopic device with any of a group of 
accessory devices which attach to the bronchoscope and is intended to 
examine or treat the larynx and tracheobronchial tree. 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 rigid ventilating 
bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, 
laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope 
tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy 
brush, rigid biopsy forceps, flexible biopsy curette, and rigid 
bronchoscope aspirating tube, but excludes the fiberoptic light source 
and carrier.
    (b) Classification. Class II.