GroundRules
21 CFR 884.5920: Vaginal insufflator.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES
- Subpart F—Obstetrical and Gynecological Therapeutic Devices
(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 of this chapter, subject to the limitations in § 884.9.
Collected 2026-08-27T02:24:47Z. Source file · JSON