CONCEIVEX LATEX-FREE SEMEN COLLECTOR
FDA 510(k) clearance K080752 · decided 2008-05-14
Clearance details
- K-number
- K080752
- Device name
- CONCEIVEX LATEX-FREE SEMEN COLLECTOR
- Applicant
- Conceivex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-03-17
- Decision date
- 2008-05-14
- Days to decision
- 58 days
- Clearance type
- Special
- Product code
- OBB
- Device class
- 2
- Regulation number
- 884.5250
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Mt. Airy, MD, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Conceivex
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| THE STORK OTC (K140186) | Rinovum Women'S Health, Inc. | 2014-07-11 |
| FOCUS TOUCH CONCEPTION SYSTEM (K112200) | Intimate Bridge 2 Conception, Inc. | 2012-09-06 |
| CONCEIVEX CONCEPTION KIT (K063227) | Conceivex, Inc. | 2007-03-14 |
Recalls involving this device
No recalls on record reference this clearance.