← Product Code [HDR](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDR) · K945131

# IMAGYN INTRAUTERINE INSEMINATION DEVICE (K945131)

_Imagyn Medical, Inc. · HDR · May 15, 1995 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDR/K945131

## Device Facts

- **Applicant:** Imagyn Medical, Inc.
- **Product Code:** [HDR](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDR.md)
- **Decision Date:** May 15, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.5250
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDR/K945131](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HDR/K945131)

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