Product Code: NBV
FDA class 2
21 CFR 884.5970
Device, Engorgement, Clitoral
Obstetrics/Gynecology
The Clitoral Engorgement Device is an obstetrics/gynecology device designed to enhance clitoral engorgement through applied vacuum or suction, intended for use in women with sexual arousal disorder or difficulty achieving engorgement. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 884.5970 (Obstetrics/Gynecology specialty).
510(k)s
3
FEI Numbers
0
Registration Numbers
0
Unique Applicants
3
Years Active
5
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Basic Information
- Product Code
- NBV
- Device Class
- FDA class 2
- Regulation Number
- 884.5970
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K043480 | ENHANCE CLITORAL STIMULATION AID | Jun 08, 2005 | Substantially Equivalent | Gynavations, Inc. |
| K001576 | EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY | Dec 28, 2000 | Substantially Equivalent | Prosurg, Inc. |
| DEN000006 | EROS-CLITORAL THERAPY DEVICE (CTD) | Apr 28, 2000 | Unknown | Urometrics, Inc. |