Clearance Summary
Hope&Her Vaginal Dilators received FDA 510(k) clearance under submission number K222492, sponsored by Lujena, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2023-06-27.
- Submission: K222492
- Applicant / Sponsor: Lujena, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.3900
- Decision date: 2023-06-27
Classification & Regulation
This clearance is catalogued under FDA product code HDX and 21 CFR 884.3900, within the Obstetrics/Gynecology review panel as a Class II device.