OBB · Class II · 21 CFR 884.5250

FDA Product Code OBB: Kit, Conception-assist, Home Use

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.

4
Total
4
Cleared
192d
Avg days
2007
Since

FDA 510(k) Cleared Kit, Conception-assist, Home Use Devices (Product Code OBB)

4 devices
1–4 of 4
No devices found for this product code.

About Product Code OBB - Regulatory Context