[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR884.4120]

[Page 457]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 884_OBSTETRICAL AND GYNECOLOGICAL DEVICES--Table of Contents
 
        Subpart E_Obstetrical and Gynecological Surgical Devices
 
Sec. 884.4120  Gynecologic electrocautery and accessories.

    (a) Identification. A gynecologic electrocautery is a device 
designed to destroy tissue with high temperatures by tissue contact with 
an electrically heated probe. It is used to excise cervical lesions, 
perform biopsies, or treat chronic cervicitis under direct visual 
observation. This generic type of device may include the following 
accessories: an electrical generator, a probe, and electrical cables.
    (b) Classification. Class II (performance standards).