Cube 4D Navigation System, VirtuEye Pro— 510(k) K261540

Substantially Equivalent

Fiagon GmbH

FDA 510(k) clearance K261540 for Cube 4D Navigation System, VirtuEye Pro, Substantially Equivalent on 2026-06-02. Applicant: Fiagon GmbH.

Clearance details

Applicant: Fiagon GmbH
Product code: Code PGW
Advisory panel: Neurology
Date received: 2026-05-08
Decision date: 2026-06-02
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, 2020-01-01 through 2026-04-23. 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.