HEC · Insufflator, Vaginal
Obstetrics/Gynecology · 21 CFR 884.5920 · Class 1
Overview
| Product Code | HEC |
|---|---|
| Device Name | Insufflator, Vaginal |
| Regulation | 21 CFR 884.5920 |
| Device Class | Class 1 |
| Review Panel | Obstetrics/Gynecology |
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.
Classification Rationale
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
