Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart D — Obstetrical and Gynecological Prosthetic Devices](/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices) → [21 CFR 884.3900](/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/884.3900) → KXP — Stent, Vaginal

# KXP · Stent, Vaginal

_Obstetrics/Gynecology · 21 CFR 884.3900 · Class 2_

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

## Overview

- **Product Code:** KXP
- **Device Name:** Stent, Vaginal
- **Regulation:** [21 CFR 884.3900](/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/884.3900)
- **Device Class:** 2
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)
- **3rd-party reviewable:** yes

## 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.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K202542](https://fda.innolitics.com/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/KXP/K202542.md) | Allura Vaginal Stent | Pmt Corporation | Sep 30, 2020 | SESE |
| [K983045](https://fda.innolitics.com/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/KXP/K983045.md) | AMIELLE | Owen Mumford USA, Inc. | Nov 25, 1998 | SESE |
| [K974479](https://fda.innolitics.com/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/KXP/K974479.md) | SILIMED VAGINAL STENT | Silimed, LLC | Aug 5, 1998 | SESE |
| [K920633](https://fda.innolitics.com/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/KXP/K920633.md) | PESSARY FLEXIBLE SILICONE NICHOLS | Bioteque America, Inc. | Nov 8, 1995 | SESE |

## Top Applicants

- Bioteque America, Inc. — 1 clearance
- Owen Mumford USA, Inc. — 1 clearance
- Pmt Corporation — 1 clearance
- Silimed, LLC — 1 clearance

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

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