HDX — Dilator, Vaginal Class II
FDA product code HDX covers "Dilator, Vaginal", a Class II medical device regulated under 21 CFR 884.3900. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 9 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HDX
- Device Class
- Class II
- Regulation Number
- 884.3900
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K241748 | plus ev holdings dba intimate rose | Intimate Rose Vaginal Dilators | August 14, 2024 |
| K233689 | lujena | Hope&Her Vaginal Dilators | May 2, 2024 |
| K222492 | lujena | Hope&Her Vaginal Dilators | June 27, 2023 |
| K231430 | plus ev holdings dba intimate rose | Intimate Rose Vaginal Dilators | June 7, 2023 |
| K220035 | materna medical | Milli Vaginal Dilator | February 27, 2023 |
| K211959 | materna medical | Milli Vaginal Dilator | December 1, 2021 |
| K130273 | panpac medical corporation | PANPAC VAGINAL DILATORS | August 8, 2013 |
| K071754 | karl storz endoscopy-america | NEO-VAGINA SURGERY SET AND ACCESSORIES | January 7, 2009 |
| K003380 | bioteque america | BIOTEQUE VAGINAL DILATOR | January 29, 2001 |