DeviceClearance

RIWOtrack Navigation System— 510(k) K230700

Substantially Equivalent

Fiagon GmbH

FDA 510(k) clearance K230700 for RIWOtrack Navigation System, Substantially Equivalent on 2023-11-20. Applicant: Fiagon GmbH.

Clearance details

Applicant
Fiagon GmbH
Product code
Code OLO
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hennigsdorf, DE
Download summary PDFView on FDA.gov ↗

Adverse events under product code OLO

product code OLO
Death
11
Injury
2,799
Malfunction
11,105
Other
1
Total
13,916

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.