DeviceClearance

K233752

Substantially Equivalent

Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps

Applicant
CenterPoint Systems, LLC
Product code
FBN
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
West Valley City, UT, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FBN

product code FBN
Death
8
Malfunction
951
Total
959

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.