BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)— 510(k) K191457

Substantially Equivalent

Med-El Elektromedizinische Geraete GmbH

FDA 510(k) clearance K191457 for BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm), Substantially Equivalent on 2019-09-18. Applicant: Med-El Elektromedizinische Geraete GmbH.

Clearance details

Applicant: Med-El Elektromedizinische Geraete GmbH
Product code: Code PFO
Advisory panel: Ear, Nose, Throat
Date received: 2019-05-31
Decision date: 2019-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Innsbruck, AT

Download summary PDF View on FDA.gov ↗

Adverse events under product code PFO

product code PFO

Injury: 2,752
Total: 2,752

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.