Clearance Summary
Silicone Personal Lubricant, ALL-IN-ONE received FDA 510(k) clearance under submission number K180083, sponsored by United Consortium. 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 2018-04-09.
- Submission: K180083
- Applicant / Sponsor: United Consortium
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2018-04-09
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.