Clearance Summary
Wet Original Personal Lubricant received FDA 510(k) clearance under submission number K160211, sponsored by Trigg Laboratories D/B/A Wet International. 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 2016-04-27.
- Submission: K160211
- Applicant / Sponsor: Trigg Laboratories D/B/A Wet International
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2016-04-27
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.