---
kind: "section"
citation: "21 C.F.R. § 884.5920"
title: "21"
number: "884.5920"
heading: "Vaginal insufflator."
url: "https://uscodex.org/cfr/21/884.5920"
---

# §884.5920. Vaginal insufflator.

- (a) **Identification.** A vaginal insufflator is a device used to treat vaginitis by introducing medicated powder from a hand-held bulb into the vagina through an open speculum.
- (b) **Classification.** Class I. The device is 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 54 FR 25052, June 12, 1989; 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 54 FR 25052, June 12, 1989; 66 FR 38809, July 25, 2001]