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) → HDX — Dilator, Vaginal

# HDX · Dilator, 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/HDX

## Overview

- **Product Code:** HDX
- **Device Name:** Dilator, 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 (9 of 9)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K241748](https://fda.innolitics.com/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HDX/K241748.md) | Intimate Rose Vaginal Dilators | Plus EV Holdings Dba Intimate Rose | Aug 14, 2024 | SESE |
| [K233689](https://fda.innolitics.com/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HDX/K233689.md) | Hope&Her Vaginal Dilators | Lujena, Inc. | May 2, 2024 | SESE |
| [K222492](https://fda.innolitics.com/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HDX/K222492.md) | Hope&Her Vaginal Dilators | Lujena, Inc. | Jun 27, 2023 | SESE |
| [K231430](https://fda.innolitics.com/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HDX/K231430.md) | Intimate Rose Vaginal Dilators | Plus EV Holdings Dba Intimate Rose | Jun 7, 2023 | SESE |
| [K220035](https://fda.innolitics.com/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HDX/K220035.md) | Milli Vaginal Dilator | Materna Medical | Feb 27, 2023 | SESE |
| [K211959](https://fda.innolitics.com/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HDX/K211959.md) | Milli Vaginal Dilator | Materna Medical | Dec 1, 2021 | SESE |
| [K130273](https://fda.innolitics.com/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HDX/K130273.md) | PANPAC VAGINAL DILATORS | Panpac Medical Corporation | Aug 8, 2013 | SESE |
| [K071754](https://fda.innolitics.com/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HDX/K071754.md) | NEO-VAGINA SURGERY SET AND ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | Jan 7, 2009 | SESE |
| [K003380](https://fda.innolitics.com/submissions/OB/subpart-d%E2%80%94obstetrical-and-gynecological-prosthetic-devices/HDX/K003380.md) | BIOTEQUE VAGINAL DILATOR | Bioteque America, Inc. | Jan 29, 2001 | SESE |

## Top Applicants

- Lujena, Inc. — 2 clearances
- Materna Medical — 2 clearances
- Plus EV Holdings Dba Intimate Rose — 2 clearances
- Bioteque America, Inc. — 1 clearance
- KARL STORZ Endoscopy-America, Inc. — 1 clearance

---

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

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