HDX · Dilator, Vaginal
Obstetrics/Gynecology · 21 CFR 884.3900 · Class 2
Overview
| Product Code | HDX |
|---|---|
| Device Name | Dilator, Vaginal |
| Regulation | 21 CFR 884.3900 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 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 | Intimate Rose Vaginal Dilators | Plus EV Holdings Dba Intimate Rose | Aug 14, 2024 | SESE |
| K233689 | Hope&Her Vaginal Dilators | Lujena, Inc. | May 2, 2024 | SESE |
| K222492 | Hope&Her Vaginal Dilators | Lujena, Inc. | Jun 27, 2023 | SESE |
| K231430 | Intimate Rose Vaginal Dilators | Plus EV Holdings Dba Intimate Rose | Jun 7, 2023 | SESE |
| K220035 | Milli Vaginal Dilator | Materna Medical | Feb 27, 2023 | SESE |
| K211959 | Milli Vaginal Dilator | Materna Medical | Dec 1, 2021 | SESE |
| K130273 | PANPAC VAGINAL DILATORS | Panpac Medical Corporation | Aug 8, 2013 | SESE |
| K071754 | NEO-VAGINA SURGERY SET AND ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | Jan 7, 2009 | SESE |
| K003380 | 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
