Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D— 510(k) K211291
Substantially EquivalentFiagon GmbH
FDA 510(k) clearance K211291 for Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D, Substantially Equivalent on 2021-07-19. Applicant: Fiagon GmbH. Device class: 2.
Clearance details
- Applicant
- Fiagon GmbH
- Product code
- Code PGW
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hennigsdorf, DE
Recent devices under product code PGW
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- K163209 — Fiagon Navigation System
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.