HDX
- Product code
- HDX
- Device name
- Dilator, Vaginal
- Device class
- Class 2
- 21 CFR
- 21 CFR 884.3900
- Medical specialty
- Obstetrics/Gynecology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 9 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K241748 | 2024-08-14 | Plus EV Holdings Dba Intimate Rose | Intimate Rose Vaginal Dilators | |
| K233689 | 2024-05-02 | Lujena, Inc. | Hope&Her Vaginal Dilators | — |
Official FDA classification page: HDX
Classification and pathway per current FDA publications. Data from openFDA (CC0).