# K201035: ETHICON Linx Esophagus Sizing Tool

- Pathway: 510(k) (Traditional)
- Applicant: Torax Medical, Inc.
- Decided: Jul 9, 2020 after 80 days
- Product code: QJN (Laparoscopic Accessories, Esophageal Sizing)
- Device class: 2
- Regulation: 21 CFR 876.5360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to DEN070003 (2008). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191422: Neural Navigator, Soterix Medical, Inc. (2020) Summary page 4.

## Most influential descendants
- K230089: ETHICON LINX® Esophagus Sizing Tool (2023), 0 descendants of its own

## Indications for use
The ETHICON Linx® Esophagus Sizing Tool for the LINX® Reflux Management System is a laparoscopic accessory used to estimate the appropriate size LINX® device.

Source page: https://510kreport.com/device/K201035
Methodology: https://510kreport.com/methodology