CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES > SUBPART B—Obstetrical and Gynecological Diagnostic Devices (§884.1040 to §884.1730) > 884.1730—Laparoscopic insufflator.

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 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 § 884.9.

Code of Federal Regulations

[45 FR 12684-12720, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38809, July 25, 2001]