510(k) K231204— Cochlear Osia® System; Cochlear Osia® OSI300 Implant; Cochlear Magnet Cassette; Cochlear Non-Magnetic Cassette; Cochlear Osia® 2(I) Sound Processor; Cochlear Osia® Fitting Software 2; Cochlear Osia® Smart App

Substantially Equivalent

Cochlear

Clearance details

Applicant: Cochlear
Product code: Code PFO
Advisory panel: Ear, Nose, Throat
Date received: 2023-04-27
Decision date: 2023-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lone Tree, CO, US

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.