Clearance Summary
U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS received FDA 510(k) clearance under submission number K112635, sponsored by Kimberly-Clark Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2011-10-07.
- Submission: K112635
- Applicant / Sponsor: Kimberly-Clark Corp.
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5470
- Decision date: 2011-10-07
Classification & Regulation
This clearance is catalogued under FDA product code HEB and 21 CFR 884.5470, within the Obstetrics/Gynecology review panel as a Class II device.