Clearance Summary
Always/Tampax bladder supports received FDA 510(k) clearance under submission number K151413, sponsored by Procter & Gamble. 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 2015-12-18.
- Submission: K151413
- Applicant / Sponsor: Procter & Gamble
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.3575
- Decision date: 2015-12-18
Classification & Regulation
This clearance is catalogued under FDA product code HHW and 21 CFR 884.3575, within the Obstetrics/Gynecology review panel as a Class II device.