← Product Code [HDX](/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HDX) · K003380

# BIOTEQUE VAGINAL DILATOR (K003380)

_Bioteque America, Inc. · HDX · Jan 29, 2001 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HDX/K003380

## Device Facts

- **Applicant:** Bioteque America, Inc.
- **Product Code:** [HDX](/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HDX.md)
- **Decision Date:** Jan 29, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.3900
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Regulatory Identification

A vaginal stent is a device used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after reconstructive surgery.

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HDX/K003380](https://fda.innolitics.com/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HDX/K003380)

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