ADHEAR System— 510(k) K172460

Substantially Equivalent

Med-El Elektromedizinische Geraete GmbH

FDA 510(k) clearance K172460 for ADHEAR System, Substantially Equivalent on 2018-04-27. Applicant: Med-El Elektromedizinische Geraete GmbH.

Clearance details

Applicant: Med-El Elektromedizinische Geraete GmbH
Product code: Code LXB
Advisory panel: Ear, Nose, Throat
Date received: 2017-08-14
Decision date: 2018-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Innsbruck, AT

Download summary PDF View on FDA.gov ↗

Adverse events under product code LXB

product code LXB

Injury: 2,334
Total: 2,334

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.