[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR884.4160]

[Page 438]
 
                        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. 884.4160  Unipolar endoscopic coagulator-cutter and accessories.

    (a) Identification. A unipolar endoscopic coagulator-cutter is a 
device designed to destroy tissue with high temperatures by directing a 
high frequency electrical current through the tissue between an 
energized probe and a grounding plate. It is used in female 
sterilization and in other operative procedures under endoscopic 
observation. This generic type of device may include the following 
accessories: an electrical generator, probes and electrical cables, and 
a patient grounding plate. This generic type of device does not include 
devices used to perform female sterilization under hysteroscopic 
observation.
    (b) Classification. Class II (performance standards).