# K161697: Acclarent NavWire Sinus Navigation Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Acclarent, Inc.
- Decided: Oct 24, 2016 after 126 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: 5 generations back to K911783 (1994). 16 ancestors in all.
3 later devices descend from it; 2 cite it directly.
3 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141456: The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer, Venterapointer, Guidewire, Pointershell, Fiagon GmbH (2014) Summary page 4.

## Most influential descendants
- K171687: Relieva SpinPlus Nav Balloon Sinuplasty System (2017), 1 descendant of its own
- K201115: Next Generation Balloon Dilation System (2020), 0 descendants of its own
- K190532: TruDi NAV Wire (2019), 0 descendants of its own

## Indications for use
The Acclarent NavWire is intended for use as a navigable guidewire to provide access to nasal and sinus spaces, and confirmation of placement in the accessed anatomy. The Acclarent NavWire is designed for use during procedures where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, can be identified relative to a CT-based model of the anatomy.

Source page: https://510kreport.com/device/K161697
Methodology: https://510kreport.com/methodology