K192068

Substantially Equivalent

i-ED COIL

Applicant: Kaneka Pharma America, LLC
Product code: HCG
Advisory panel: Neurology
Date received: 2019-08-01
Decision date: 2020-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Adverse events under product code HCG

product code HCG

Death: 50
Injury: 801
Malfunction: 5,625
Total: 6,476

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.