Fiagon Navigation System— 510(k) K151156
Substantially EquivalentFiagon GmbH
FDA 510(k) clearance K151156 for Fiagon Navigation System, Substantially Equivalent on 2016-04-01. Applicant: Fiagon GmbH. Device class: 2.
Clearance details
- Applicant
- Fiagon GmbH
- Product code
- Code HAW
- 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 HAW
view allMore clearances from Fiagon GmbH
view all- K261540 — Cube 4D Navigation System, VirtuEye Pro
- K230700 — RIWOtrack Navigation System
- K230065 — VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav Balloon Dilation System, VenSure ET Balloon Dilation System
- K211291 — Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D
- K201472 — VenSure Balloon Device, VenSure Nav Balloon Device
Adverse events under product code HAW
product code HAW- Death
- 52
- Injury
- 1,083
- Malfunction
- 17,300
- Total
- 18,435
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.