OBB — Kit, Conception-Assist, Home Use Class II
Classification Details
- Product Code
- OBB
- Device Class
- Class II
- Regulation Number
- 884.5250
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K140186 | rinovum women health | THE STORK OTC | July 11, 2014 |
| K112200 | intimate bridge 2 conception | FOCUS TOUCH CONCEPTION SYSTEM | September 6, 2012 |
| K080752 | conceivex | CONCEIVEX LATEX-FREE SEMEN COLLECTOR | May 14, 2008 |
| K063227 | conceivex | CONCEIVEX CONCEPTION KIT | March 14, 2007 |