i-ED COIL System— 510(k) K210638

Name: FDA 510(k) clearance K210638
Creator: U.S. Food and Drug Administration
Published: 2021-03-26

Substantially Equivalent

Kaneka Medical America, LLC

FDA 510(k) clearance K210638 for i-ED COIL System, Substantially Equivalent on 2021-03-26. Applicant: Kaneka Medical America, LLC. Device class: 2.

Clearance details

Applicant: Kaneka Medical America, LLC
Product code: Code HCG
Device class: Class 2
Regulation: 21 CFR 882.5950
Advisory panel: Neurology
Date received: 2021-03-03
Decision date: 2021-03-26
Decision: Substantially Equivalent
Clearance type: Special
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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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.