510(k) K023870— FLEXIMA BILIARY CATHETER

Substantially Equivalent

Boston Scientific/Medi-Tech

Clearance details

Applicant: Boston Scientific/Medi-Tech
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 2002-11-20
Decision date: 2002-12-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Natick,, MA, US

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.