Clearance Summary
Intimate Rose Vaginal Dilators received FDA 510(k) clearance under submission number K241748, sponsored by Plus EV Holdings Dba Intimate Rose. 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 2024-08-14.
- Submission: K241748
- Applicant / Sponsor: Plus EV Holdings Dba Intimate Rose
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.3900
- Decision date: 2024-08-14
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.