EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY
FDA 510(k) clearance K001576 · decided 2000-12-28
Clearance details
- K-number
- K001576
- Device name
- EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY
- Applicant
- Prosurg, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-05-22
- Decision date
- 2000-12-28
- Days to decision
- 220 days
- Clearance type
- Traditional
- Product code
- NBV
- Device class
- 2
- Regulation number
- 884.5970
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ENHANCE CLITORAL STIMULATION AID (K043480) | Gynavations, Inc. | 2005-06-08 |
| EROS-CLITORAL THERAPY DEVICE (CTD) (DEN000006) | Urometrics, Inc. | 2000-04-28 |
Recalls involving this device
No recalls on record reference this clearance.