K250488
- 510(k) number
- K250488
- Device name
- Cerynë Intimate Care
- Applicant
- Ansella Therapeutics TX · US
- Product code
- NUC — Lubricant, Personal
- Decision date
- 2025-12-12
- Date received
- 2025-02-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
510(k) Summary (official FDA PDF): K250488.pdf
Official FDA record: K250488
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.