# K141456: The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer, Venterapointer, Guidewire, Pointershell

- Pathway: 510(k) (Traditional)
- Applicant: Fiagon GmbH
- Decided: Oct 8, 2014 after 128 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). 15 ancestors in all.
13 later devices descend from it; 6 cite it directly.
3 of 29 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.
- K133665: Malleable Suction Instruments, Medtronic Navigation, Inc. (2014) Summary page 4.
- K960330: Instatrak, Visualization Technology, Inc. (1996) Summary page 4.

## Most influential descendants
- K171661: Scopis Extended Instrument Set EM (2017), 3 descendants of its own
- K161697: Acclarent NavWire Sinus Navigation Guidewire (2016), 3 descendants of its own
- K160369: GuideWire (2016), 3 descendants of its own
- K161940: Guidewire 0.6 Single Use (2016), 2 descendants of its own
- K193118: TGS Guidewire and updated Scopis Software (2020), 1 descendant of its own

## Indications for use
The Fiagon Navigation – Extended Instrument Set ENT is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation. The Fiagon Navigation – Extended Instrument Set ENT 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. Skull base procedures for ENT access

Source page: https://510kreport.com/device/K141456
Methodology: https://510kreport.com/methodology