Product code HDX
- Device name
- Dilator, Vaginal
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.3900
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241748 | Intimate Rose Vaginal Dilators | Plus EV Holdings Dba Intimate Rose | 2024-08-14 |
| K233689 | Hope&Her Vaginal Dilators | Lujena, Inc. | 2024-05-02 |
| K222492 | Hope&Her Vaginal Dilators | Lujena, Inc. | 2023-06-27 |
| K231430 | Intimate Rose Vaginal Dilators | Plus EV Holdings Dba Intimate Rose | 2023-06-07 |
| K220035 | Milli Vaginal Dilator | Materna Medical | 2023-02-27 |
| K211959 | Milli Vaginal Dilator | Materna Medical | 2021-12-01 |
| K130273 | PANPAC VAGINAL DILATORS | Panpac Medical Corporation | 2013-08-08 |
| K071754 | NEO-VAGINA SURGERY SET AND ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | 2009-01-07 |
| K003380 | BIOTEQUE VAGINAL DILATOR | Bioteque America, Inc. | 2001-01-29 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04262494460791 | N/A | Doppkon GmbH & Co. KG | 2025-09-10 |
| 00810142352307 | Bioteque America, Inc. | Bioteque America, Inc. | 2025-05-30 |
| 00810142352277 | Bioteque America, Inc. | Bioteque America, Inc. | 2025-05-29 |
| 00810142352260 | Bioteque America, Inc. | Bioteque America, Inc. | 2025-05-29 |
| 00810142352246 | Bioteque America, Inc. | Bioteque America, Inc. | 2025-05-29 |
| 00810142352239 | Bioteque America, Inc. | Bioteque America, Inc. | 2025-05-29 |
| 00810142352222 | Bioteque America, Inc. | Bioteque America, Inc. | 2025-05-29 |
| 00810142352215 | Bioteque America, Inc. | Bioteque America, Inc. | 2025-05-29 |
| 00850005838067 | Intimate Rose | PLUS EV HOLDINGS INC. | 2024-12-10 |
| 00850005838128 | Intimate Rose | PLUS EV HOLDINGS INC. | 2024-12-10 |
| 00850005838111 | Intimate Rose | PLUS EV HOLDINGS INC. | 2024-12-10 |
| 00850005838104 | Intimate Rose | PLUS EV HOLDINGS INC. | 2024-12-10 |
| 00850005838098 | Intimate Rose | PLUS EV HOLDINGS INC. | 2024-12-10 |
| 00850005838081 | Intimate Rose | PLUS EV HOLDINGS INC. | 2024-12-10 |
| 00850005838074 | Intimate Rose | PLUS EV HOLDINGS INC. | 2024-12-10 |
| 00850005838050 | Intimate Rose | PLUS EV HOLDINGS INC. | 2024-12-10 |
| 00850005838043 | Intimate Rose | PLUS EV HOLDINGS INC. | 2024-12-10 |
| 00850005838036 | Intimate Rose | PLUS EV HOLDINGS INC. | 2024-12-10 |
| 00850005838029 | Intimate Rose | PLUS EV HOLDINGS INC. | 2024-12-10 |
| 04719894432304 | Bioteque | Bioteque Taiwan Ltd. | 2024-04-08 |
| 04719894432298 | Bioteque | Bioteque Taiwan Ltd. | 2024-04-08 |
| 04719894432281 | Bioteque | Bioteque Taiwan Ltd. | 2024-04-08 |
| 04719894432274 | Bioteque | Bioteque Taiwan Ltd. | 2024-04-08 |
| 04719894432267 | Bioteque | Bioteque Taiwan Ltd. | 2024-04-08 |
| 04719894432250 | Bioteque | Bioteque Taiwan Ltd. | 2024-04-08 |
| 04719894432243 | Bioteque | Bioteque Taiwan Ltd. | 2024-04-08 |
| 04719894432236 | Bioteque | Bioteque Taiwan Ltd. | 2024-04-08 |
| 04719894432205 | Bioteque | Bioteque Taiwan Ltd. | 2024-03-29 |
| 04719894432229 | Bioteque | Bioteque Taiwan Ltd. | 2024-03-29 |
| 04719894432212 | Bioteque | Bioteque Taiwan Ltd. | 2024-03-29 |