Clearance Summary
Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid) received FDA 510(k) clearance under submission number K191480, sponsored by Trigg Laboratories, Inc. 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 2019-10-11.
- Submission: K191480
- Applicant / Sponsor: Trigg Laboratories, Inc. D/B/A Wet International
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2019-10-11
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.