Clearance Summary
K-Y BRAND LIQUIBEADS received FDA 510(k) clearance under submission number K122061, sponsored by Johnson & Johnson Healthcare Products. 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 2013-11-08.
- Submission: K122061
- Applicant / Sponsor: Johnson & Johnson Healthcare Products
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2013-11-08
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.