K261540
- 510(k) number
- K261540
- Device name
- Cube 4D Navigation System, VirtuEye Pro
- Applicant
- Fiagon GmbH DE
- Product code
- PGW — Ear, Nose, And Throat Stereotaxic Instrument
- Decision date
- 2026-06-02
- Date received
- 2026-05-08
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K261540.pdf
Official FDA record: K261540
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.