[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: 21CFR874.4720]

[Page 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. 874.4720  Mediastinoscope and accessories.

    (a) Identification. A mediastinoscope and accessories is a tubular 
tapered electrical endoscopic device with any of a group of accessory 
devices which attach to the mediastinoscope and is intended to examine 
or treat tissue in the area separating the lungs. The device is inserted 
transthoracicly and is used in diagnosis of tumors and lesions and to 
determine whether excision of certain organs or tissues is indicated. It 
is typically used with a fiberoptic light source and carrier to provide 
illumination. The device is made of materials such as stainless steel. 
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.