[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: 21CFR884.1730]

[Page 432-433]
 
                        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. 884.1730  Laparoscopic insufflator.

    (a) Identification. A laparoscopic insufflator is a device used to 
facilitate

[[Page 433]]

the use of the laparoscope by filling the peritoneal cavity with gas to 
distend it.
    (b) Classification. (1) Class II (performance standards).
    (2) Class I for tubing and tubing/filter kits which include 
accessory instruments that are not used to effect intra-abdominal 
insufflation (pneumoperitoneum). 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 1124, Jan. 16, 
1996; 66 FR 38809, July 25, 2001]