NBV · Device, Engorgement, Clitoral
Obstetrics/Gynecology · 21 CFR 884.5970 · Class 2
Overview
| Product Code | NBV |
|---|---|
| Device Name | Device, Engorgement, Clitoral |
| Regulation | 21 CFR 884.5970 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
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.
Classification Rationale
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.”
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.”
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K043480 | ENHANCE CLITORAL STIMULATION AID | Gynavations, Inc. | Jun 8, 2005 | SESE |
| K001576 | EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY | Prosurg, Inc. | Dec 28, 2000 | SESE |
| DEN000006 | EROS-CLITORAL THERAPY DEVICE (CTD) | Urometrics, Inc. | Apr 28, 2000 | DENG |
Top Applicants
- Gynavations, Inc. — 1 clearance
- Prosurg, Inc. — 1 clearance
- Urometrics, Inc. — 1 clearance
