DeviceClearance

K163416

Substantially Equivalent

Fiagon Navigation – PointerTube Straight and PointerTube Keat

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.