[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: 21CFR884.1640]

[Page 431]
 
                        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. 884.1640  Culdoscope and accessories.

    (a) Identification. A culdoscope is a device designed to permit 
direct viewing of the organs within the peritoneum by a telescopic 
system introduced into the pelvic cavity through the posterior vaginal 
fornix. 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 
preheaters, light source and cables, and component parts.
    (b) Classification. (1) Class II (performance standards).
    (2) Class I for culdoscope 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 culdoscope accessory instruments include: 
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, 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]