Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart F — Obstetrical and Gynecological Therapeutic Devices](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices) → [21 CFR 884.5250](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/884.5250) → OBB — Kit, Conception-Assist, Home Use

# OBB · Kit, Conception-Assist, Home Use

_Obstetrics/Gynecology · 21 CFR 884.5250 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/OBB

## Overview

- **Product Code:** OBB
- **Device Name:** Kit, Conception-Assist, Home Use
- **Regulation:** [21 CFR 884.5250](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/884.5250)
- **Device Class:** 2
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)

## 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](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/OBB/K140186.md) | THE STORK OTC | Rinovum Women'S Health, Inc. | Jul 11, 2014 | SESE |
| [K112200](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/OBB/K112200.md) | FOCUS TOUCH CONCEPTION SYSTEM | Intimate Bridge 2 Conception, Inc. | Sep 6, 2012 | SESE |
| [K080752](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/OBB/K080752.md) | CONCEIVEX LATEX-FREE SEMEN COLLECTOR | Conceivex, Inc. | May 14, 2008 | SESE |
| [K063227](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/OBB/K063227.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/OBB](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/OBB)

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