Clearance Summary
ADHEAR System received FDA 510(k) clearance under submission number K172460, sponsored by Med-El Elektromedizinische Geraete GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2018-04-27.
- Submission: K172460
- Applicant / Sponsor: Med-El Elektromedizinische Geraete GmbH
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3302
- Decision date: 2018-04-27
Classification & Regulation
This clearance is catalogued under FDA product code LXB and 21 CFR 874.3302, within the Ear, Nose, Throat review panel as a Class II device.