510(k) K190589— Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments

Substantially Equivalent

Cochlear Americas

Clearance details

Applicant: Cochlear Americas
Product code: Code PFO
Advisory panel: Ear, Nose, Throat
Date received: 2019-03-07
Decision date: 2019-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Centennial, 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.