← Product Code [HHW](/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HHW) · K920187

# FLEXIBLE SILICONE GELIHORN (K920187)

_Bioteque America, Inc. · HHW · Oct 23, 1992 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HHW/K920187

## Device Facts

- **Applicant:** Bioteque America, Inc.
- **Product Code:** [HHW](/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HHW.md)
- **Decision Date:** Oct 23, 1992
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.3575
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Regulatory Identification

A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HHW/K920187](https://fda.innolitics.com/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HHW/K920187)

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