SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, AND EX8S3005— 510(k) K033537

Unknown

Abbott Laboratories

FDA 510(k) clearance K033537 for SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, AND EX8S3005, Unknown on 2003-12-10. Applicant: Abbott Laboratories.

Clearance details

Applicant: Abbott Laboratories
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 2003-11-10
Decision date: 2003-12-10
Decision: Unknown
Clearance type: Special
Location: Redwood, 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.