Clearance Summary
Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming received FDA 510(k) clearance under submission number K200457, sponsored by CC Wellness, LLC. 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 2020-05-22.
- Submission: K200457
- Applicant / Sponsor: CC Wellness, LLC
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2020-05-22
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.