THE STORK OTC
FDA 510(k) clearance K140186 · decided 2014-07-11
Clearance details
- K-number
- K140186
- Device name
- THE STORK OTC
- Applicant
- Rinovum Women'S Health, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-01-24
- Decision date
- 2014-07-11
- Days to decision
- 168 days
- Clearance type
- Traditional
- Product code
- OBB
- Device class
- 2
- Regulation number
- 884.5250
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Monroeville, PA, 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 |
|---|---|---|
| FOCUS TOUCH CONCEPTION SYSTEM (K112200) | Intimate Bridge 2 Conception, Inc. | 2012-09-06 |
| CONCEIVEX LATEX-FREE SEMEN COLLECTOR (K080752) | Conceivex, Inc. | 2008-05-14 |
| CONCEIVEX CONCEPTION KIT (K063227) | Conceivex, Inc. | 2007-03-14 |
Recalls involving this device
No recalls on record reference this clearance.