OBB · Kit, Conception-Assist, Home Use
Obstetrics/Gynecology · 21 CFR 884.5250 · Class 2
Overview
| Product Code | OBB |
|---|---|
| Device Name | Kit, Conception-Assist, Home Use |
| Regulation | 21 CFR 884.5250 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
Identification
A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K140186 | THE STORK OTC | Rinovum Women'S Health, Inc. | Jul 11, 2014 | SESE |
| K112200 | FOCUS TOUCH CONCEPTION SYSTEM | Intimate Bridge 2 Conception, Inc. | Sep 6, 2012 | SESE |
| K080752 | CONCEIVEX LATEX-FREE SEMEN COLLECTOR | Conceivex, Inc. | May 14, 2008 | SESE |
| K063227 | CONCEIVEX CONCEPTION KIT | Conceivex, Inc. | Mar 14, 2007 | SESE |
Top Applicants
- Conceivex, Inc. — 2 clearances
- Intimate Bridge 2 Conception, Inc. — 1 clearance
- Rinovum Women'S Health, Inc. — 1 clearance
