BAHA CORDELLE II— 510(k) K080363

Name: FDA 510(k) clearance K080363
Creator: U.S. Food and Drug Administration
Published: 2008-04-10

Substantially Equivalent

Cochlear Bone Anchored Systems AB

FDA 510(k) clearance K080363 for BAHA CORDELLE II, Substantially Equivalent on 2008-04-10. Applicant: Cochlear Bone Anchored Systems AB. Device class: 2.

Clearance details

Applicant: Cochlear Bone Anchored Systems AB
Product code: Code MAH
Device class: Class 2
Regulation: 21 CFR 874.3302
Advisory panel: Ear, Nose, Throat
Date received: 2008-02-11
Decision date: 2008-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MAH

product code MAH

Injury: 4,155
Total: 4,155

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.