# K162176: Fiagon Navigation System

- Pathway: 510(k) (Special)
- Applicant: Fiagon GmbH
- Decided: Dec 1, 2016 after 120 days
- Product code: PGW (Ear, Nose, And Throat Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K911783 (1994). 13 ancestors in all.
4 later devices descend from it; 2 cite it directly.
3 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133573: Fiagon Navigation System, Fiagon GmbH (2014) Summary page 4.

## Most influential descendants
- K211291: Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D (2021), 1 descendant of its own
- K192397: TruDi Navigation System (2020), 1 descendant of its own
- K261540: Cube 4D Navigation System, VirtuEye Pro (2026), 0 descendants of its own
- K231862: TruDi® Navigation System V3 (FG-2000-00) (2023), 0 descendants of its own

## Indications for use
The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The Fiagon Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy. Example procedures include, but are not limited to: ENT Procedures; Transphenoidal access procedures. Intranasal procedures. Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies. ENT related anterior skull base procedures.

Source page: https://510kreport.com/device/K162176
Methodology: https://510kreport.com/methodology