Product code OBB— Obstetrics/Gynecology

“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.”

FDA has cleared 4 devices under product code OBB between 2007 and 2014, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20141 clearance
• 20121 clearance
• 20081 clearance
• 20071 clearance

• Conceivex, Inc.2 clearances
• Rinovum Women'S Health, Inc.1 clearance
• Intimate Bridge 2 Conception, Inc.1 clearance

• K140186 — THE STORK OTCRinovum Women'S Health, Inc.·2014-07-11
• K112200 — FOCUS TOUCH CONCEPTION SYSTEMIntimate Bridge 2 Conception, Inc.·2012-09-06
• K080752 — CONCEIVEX LATEX-FREE SEMEN COLLECTORConceivex, Inc.·2008-05-14
• K063227 — CONCEIVEX CONCEPTION KITConceivex, Inc.·2007-03-14