[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: 21CFR884.1690]

[Page 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. 884.1690  Hysteroscope and accessories.

    (a) Identification. A hysteroscope is a device used to permit direct 
viewing of the cervical canal and the uterine cavity by a telescopic 
system introduced into the uterus through the cervix. It is used to 
perform diagnostic and surgical procedures other than sterilization. 
This generic type of device may include obturators and sheaths, 
instruments used through an operating channel, scope preheaters, light 
sources and cables, and component parts.
    (b) Classification. (1) Class II (performance standards).
    (2) Class I for hysteroscope accessories that are not part of a 
specialized instrument or device delivery system; do not have adapters, 
connectors, channels, or do not have portals for electrosurgical, laser, 
or other power sources. Such hysteroscope accessory instruments include: 
lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/
grasper, curette, instrument guide, forceps, dissector, mechanical 
(noninflatable), and scissors. The devices subject to this paragraph 
(b)(2) are exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter, subject to the limitations in Sec. 884.9.

[45 FR 12684-12720, Feb. 26, 1980, as amended at 61 FR 1123, Jan. 16, 
1996; 66 FR 38808, July 25, 2001]