Clearance Summary
Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) received FDA 510(k) clearance under submission number K252914, sponsored by Hathor Professional Skincare , Ltd.. 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 2026-06-09.
- Submission: K252914
- Applicant / Sponsor: Hathor Professional Skincare , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2026-06-09
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.