LIFESTENT FLEXSTART BILIARY STENT SYSTEM— 510(k) K053404

Unknown

Edwards Lifesciences, LLC

FDA 510(k) clearance K053404 for LIFESTENT FLEXSTART BILIARY STENT SYSTEM, Unknown on 2005-12-21. Applicant: Edwards Lifesciences, LLC.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 2005-12-07
Decision date: 2005-12-21
Decision: Unknown
Clearance type: Special
Location: Irvine, CA, US

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Adverse events under product code FGE

product code FGE

Death: 52
Injury: 2,347
Malfunction: 9,798
Other: 1
Total: 12,198

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.