[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR884.1720]

[Page 415-416]
 
                        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. 884.1720  Gynecologic laparoscope and accessories.

    (a) Identification. A gynecologic laparoscope is a device used to 
permit direct viewing of the organs within the peritoneum by a 
telescopic system introduced through the abdominal wall. It is used to 
perform diagnostic and surgical procedures on the female genital organs. 
This generic type of device may include: Trocar and cannula, instruments 
used through an operating channel, scope preheater, light source and 
cables, and component parts.
    (b) Classification. (1) Class II (performance standards).
    (2) Class I for gynecologic laparoscope accessories that are not 
part of a specialized instrument or device delivery system, do not have 
adapters, connector channels, or do not

[[Page 416]]

have portals for electrosurgical, lasers, or other power sources. Such 
gynecologic laparoscope accessory instruments include: the lens cleaning 
brush, biopsy brush, clip applier (without clips), applicator, cannula 
(without trocar or valves), ligature carrier/needle holder, clamp/
hemostat/grasper, curette, instrument guide, ligature passing and 
knotting instrument, suture needle (without suture), retractor, 
mechanical (noninflatable), snare, stylet, forceps, dissector, 
mechanical (noninflatable), scissors, and suction/irrigation probe. The 
devices subject to this paragraph (b)(2) are exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[45 FR 12684-12720, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 
1996]