[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: 21CFR884.1730]

[Page 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. 884.1730  Laparoscopic insufflator.

    (a) Identification. A laparoscopic insufflator is a device used to 
facilitate 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 which are not used to effect intra-abdominal 
access, Verres needles etc.; and single-use tubing kits used for only 
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.

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