Clearance Summary
Cerynë Intimate Care received FDA 510(k) clearance under submission number K250488, sponsored by Ansella Therapeutics. 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 2025-12-12.
- Submission: K250488
- Applicant / Sponsor: Ansella Therapeutics
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2025-12-12
Classification & Regulation
This clearance is catalogued under FDA product code NUC and 21 CFR 884.5300, within the Obstetrics/Gynecology review panel as a Class II device.