DeviceClearance

K200041

Substantially Equivalent

FlexPointer 1.5 Single Use, FlexTube 3 Single Use

Applicant
Fiagon GmbH
Product code
PGW
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Hennigsdorf, DE
Download summary PDF View on FDA.gov ↗

Adverse events under product code PGW

product code PGW
Malfunction
1,199
Total
1,199

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.