Kit, Conception-Assist, Home Use
The Kit, Conception-Assist, Home Use (product code OBB) is a home-use kit intended to assist conception in situations involving low sperm count, sperm immobility, or hostile vaginal environment, comprising cervical caps for semen collection and placement, polyurethane condoms, ovulation predictors, pregnancy tests, lubricant samples, and instructional materials, intended for use at home following physician instruction. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 884.5250 within the Obstetrics/Gynecology specialty. The device carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OBB
- Device Class
- FDA class 2
- Regulation Number
- 884.5250
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K140186 | THE STORK OTC | Jul 11, 2014 | Substantially Equivalent | Rinovum Women'S Health, Inc. |
| K112200 | FOCUS TOUCH CONCEPTION SYSTEM | Sep 06, 2012 | Substantially Equivalent | Intimate Bridge 2 Conception, Inc. |
| K080752 | CONCEIVEX LATEX-FREE SEMEN COLLECTOR | May 14, 2008 | Substantially Equivalent | Conceivex, Inc. |
| K063227 | CONCEIVEX CONCEPTION KIT | Mar 14, 2007 | Substantially Equivalent | Conceivex, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.