FIAGON NAVIGATION SYSTEM— 510(k) K133573
Substantially EquivalentFiagon GmbH
FDA 510(k) clearance K133573 for FIAGON NAVIGATION SYSTEM, Substantially Equivalent on 2014-04-30. 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
view allMore clearances from Fiagon GmbH
view all- 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
- K200041 — FlexPointer 1.5 Single Use, FlexTube 3 Single Use
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.