OBB — Kit, Conception-Assist, Home Use Class II

FDA Device Classification

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-NumberApplicantDevice NameDate
K140186rinovum women healthTHE STORK OTCJuly 11, 2014
K112200intimate bridge 2 conceptionFOCUS TOUCH CONCEPTION SYSTEMSeptember 6, 2012
K080752conceivexCONCEIVEX LATEX-FREE SEMEN COLLECTORMay 14, 2008
K063227conceivexCONCEIVEX CONCEPTION KITMarch 14, 2007