Clearance Summary
BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm) received FDA 510(k) clearance under submission number K191457, 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 2019-09-18.
- Submission: K191457
- Applicant / Sponsor: Med-El Elektromedizinische Geraete GmbH
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3340
- Decision date: 2019-09-18
Classification & Regulation
This clearance is catalogued under FDA product code PFO and 21 CFR 874.3340, within the Ear, Nose, Throat review panel as a Class II device.