---
kind: "section"
citation: "21 C.F.R. § 884.1730"
title: "21"
number: "884.1730"
heading: "Laparoscopic insufflator."
url: "https://uscodex.org/cfr/21/884.1730"
---

# §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)](#b-2) are exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter, subject to the limitations in [§ 884.9](/cfr/21/884.9.md).

## Notes

### Amendments

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

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.

### Source

Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.

### Amendments

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