K233689
- 510(k) number
- K233689
- Device name
- Hope&Her Vaginal Dilators
- Applicant
- Lujena, Inc. CA · US
- Product code
- HDX — Dilator, Vaginal
- Decision date
- 2024-05-02
- Date received
- 2023-11-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K233689
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.