# K161701: CARTO ENT System

- Pathway: 510(k) (Traditional)
- Applicant: Biosense Webster
- 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: 4 generations back to K911783 (1994). 13 ancestors in all.
3 later devices descend from it; 1 cites it directly.
3 of 17 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
- K173628: Acclarent ENT Navigation System (2018), 2 descendants of its own
- K192397: TruDi Navigation System (2020), 1 descendant of its own
- K231862: TruDi® Navigation System V3 (FG-2000-00) (2023), 0 descendants of its own

## Indications for use
The CARTO® ENT System is intended for use during intranasal and paranasal image-guided navigation procedures for patients who are cligible for sinus procedures.

Source page: https://510kreport.com/device/K161701
Methodology: https://510kreport.com/methodology