Clearance Summary
Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.) received FDA 510(k) clearance under submission number K251773, sponsored by Shenzhen Yongquan Medical Devices Co., 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 2025-09-09.
- Submission: K251773
- Applicant / Sponsor: Shenzhen Yongquan Medical Devices Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2025-09-09
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.