510(k) K063227
K063227 is an FDA 510(k) premarket notification submitted by Conceivex, Inc. for the device "CONCEIVEX CONCEPTION KIT". The FDA issued a decision of Substantially Equivalent on March 14, 2007. The device falls under product code OBB (Kit, Conception-Assist, Home Use), a Class II device regulated under 21 CFR 884.5250. Conceivex, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 14, 2007
- Date Received
- October 24, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Conception-Assist, Home Use
- Device Class
- Class II
- Regulation Number
- 884.5250
- Review Panel
- OB
- Submission Type
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.