OBB
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Kit, Conception-Assist, Home Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5250
- Medical specialty
- Obstetrics/Gynecology
- FDA definition
- The kit is intended for assisted insemination in situations in which low sperm count , sperm immobility, or hostile vaginal environment have been diagnosed. The kit is used for semen collection and placement into the bowl of a cervical cap as an aid to conception. It is to be used at home following physician instruction. The Cap should not be left in place for more than 6 hours. The kit consists of: conception (cervical) caps; 3 polyurethane condoms; 24 ovulation predictors; 3 pregnancy test kits; 3 "sperm friendly" moisturizer samples (Pre Lubricant); 1 conception journal; 1 instruction manual; 2 conception wheels (1 in English and 1 in French); 1 medical provider envelope.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| 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 LATEX-FREE SEMEN COLLECTOR (K080752) | Conceivex, Inc. | 2008-05-14 |
| CONCEIVEX CONCEPTION KIT (K063227) | Conceivex, Inc. | 2007-03-14 |
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Every clearance here is in the API, with alerts when new ones post.