EDWARDS E360 SURGICAL ABLATION DEVICE— 510(k) K041739

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K041739 for EDWARDS E360 SURGICAL ABLATION DEVICE, Substantially Equivalent on 2004-09-29. Applicant: Edwards Lifesciences, LLC.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2004-06-28
Decision date: 2004-09-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

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Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

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.