Clearance Summary
TULA Iontophoresis System with Earset received FDA 510(k) clearance under submission number K150453, sponsored by Acclarent, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2015-05-20.
- Submission: K150453
- Applicant / Sponsor: Acclarent, Inc.
- Clearance pathway: Special
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5525
- Decision date: 2015-05-20
Classification & Regulation
This clearance is catalogued under FDA product code EGJ and 21 CFR 890.5525, within the Physical Medicine review panel as a Class II device.