← Product Code [HHW](/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HHW) · K920747

# PESSARY FLEXIBLE SILICONE DONUT RING (K920747)

_Bioteque America, Inc. · HHW · Aug 29, 1994 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HHW/K920747

## Device Facts

- **Applicant:** Bioteque America, Inc.
- **Product Code:** [HHW](/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HHW.md)
- **Decision Date:** Aug 29, 1994
- **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/K920747](https://fda.innolitics.com/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HHW/K920747)

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