[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: 21CFR884.1660]

[Page 431-432]
 
                        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 B--Obstetrical and Gynecological Diagnostic Devices
 
Sec. 884.1660  Transcervical endoscope (amnioscope) and accessories.

    (a) Identification. A transcervical endoscope is a device designed 
to permit direct viewing of the fetus and amniotic sac by means of an 
open tube introduced into the uterus through the

[[Page 432]]

cervix. The device may be used to visualize the fetus or amniotic fluid 
and to sample fetal blood or amniotic fluid. This generic type of device 
may include obturators, instruments used through an operating channel, 
light sources and cables, and component parts.
    (b) Classification. Class II (performance standards).