# K133573: Fiagon Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Fiagon GmbH
- Decided: Apr 30, 2014 after 161 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: 3 generations back to K911783 (1994). 12 ancestors in all.
28 later devices descend from it; 8 cite it directly.
3 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001284: Stealthstation System Goldeneye Micro-Magnetic Tracking System, Medtronic Surgical Navigation Technologies (2000) Summary page 1.
- K960330: Instatrak, Visualization Technology, Inc. (1996) Summary page 1.
- K983529: Instatrak 3000, Visualization Technology, Inc. (1998) Summary page 1.
- K964229: Regulus Navigator, Compass Intl., Inc. (1997) Summary page 1.

## Most influential descendants
- K141456: The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer, Venterapointer, Guidewire, Pointershell (2014), 13 descendants of its own
- K162176: Fiagon Navigation System (2016), 4 descendants of its own
- K171661: Scopis Extended Instrument Set EM (2017), 3 descendants of its own
- K161491: Scopis Hybrid Navigation System EM (2017), 3 descendants of its own
- K161701: CARTO ENT System (2016), 3 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, Sphenoidiotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomides. ENT related anterior skull base procedures

Source page: https://510kreport.com/device/K133573
Methodology: https://510kreport.com/methodology