DeviceClearance

K081733

Substantially Equivalent

10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890

Applicant
Boston Scientific Corp
Product code
FGE
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Marlboro, MA, US
Download summary PDF View on FDA.gov ↗

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, through . 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.