FDA product code NBV: Device, Engorgement, Clitoral
NBV is the FDA product code for device, engorgement, clitoral. It is a Class II device, regulated under 21 CFR 884.5970 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 2 510(k) submissions under NBV, from 2 different applicants. The average 510(k) review took 197 days (median 197). 1 De Novo request was granted under it.
Classification
| Field | Value |
|---|---|
| Device name | Device, Engorgement, Clitoral |
| Device class | Class II |
| Regulation | 21 CFR 884.5970 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NBV clearance
Top NBV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gynavations, Inc. | 1 | 2005-06-08 |
| Prosurg, Inc. | 1 | 2000-12-28 |
Most recent NBV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K043480 | Gynavations, Inc. | ENHANCE CLITORAL STIMULATION AID | 2005-06-08 | 174 |
| K001576 | Prosurg, Inc. | EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY | 2000-12-28 | 220 |
Recalls for NBV devices
openFDA lists no recalls for product code NBV.
Frequently asked questions
What is FDA product code NBV?
NBV is the FDA product code for device, engorgement, clitoral. It is a Class II device, regulated under 21 CFR 884.5970 and reviewed by the Obstetrics and Gynecology panel.
What device class is NBV?
Class II, regulation 21 CFR 884.5970. Typical premarket route: 510(k).
How long does a 510(k) take for product code NBV?
Across 2 cleared submissions the average was 197 days from receipt to decision (median 197).
Which companies have the most NBV clearances?
Gynavations, Inc. (1); Prosurg, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NBV
- Run a recall and safety report across every NBV manufacturer
- Watch product code NBV for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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