Clearance Summary
SABA Tampons received FDA 510(k) clearance under submission number K242105, sponsored by Essity Higiene Y Salud Mexico. S.A. DE C.V.. 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 2025-04-01.
- Submission: K242105
- Applicant / Sponsor: Essity Higiene Y Salud Mexico. S.A. DE C.V.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5470
- Decision date: 2025-04-01
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.