EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY
Device Facts
| Record ID | K001576 |
|---|---|
| Device Name | EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY |
| Applicant | Prosurg, Inc. |
| Product Code | NBV · Obstetrics/Gynecology |
| Decision Date | Dec 28, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5970 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A clitoral engorgement device is designed to apply a vacuum to the clitoris. It is intended for use in the treatment of female sexual arousal disorder.
Special Controls
*Classification.* Class II (special controls). The special control is a guidance document entitled: “Guidance for Industry and FDA Reviewers: Class II Special Controls Guidance Document for Clitoral Engorgement Devices.”
