RIWOtrack Navigation System— 510(k) K230700
Substantially EquivalentFiagon GmbH
FDA 510(k) clearance K230700 for RIWOtrack Navigation System, Substantially Equivalent on 2023-11-20. Applicant: Fiagon GmbH. Device class: 2.
Clearance details
- Applicant
- Fiagon GmbH
- Product code
- Code OLO
- 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 OLO
view allMore clearances from Fiagon GmbH
view all- K261540 — Cube 4D Navigation System, VirtuEye Pro
- 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
- K200041 — FlexPointer 1.5 Single Use, FlexTube 3 Single Use
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.