Clearance Summary
K-Y BRAND LONG LASTING VAGINAL MOISTURIZER received FDA 510(k) clearance under submission number K101585, sponsored by Johnson & Johnson Consumer & Personal Products Wor. 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 2011-05-10.
- Submission: K101585
- Applicant / Sponsor: Johnson & Johnson Consumer & Personal Products Wor
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2011-05-10
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.