# K230089: ETHICON LINX® Esophagus Sizing Tool

- Pathway: 510(k) (Special)
- Applicant: Torax Medical, Inc.
- Decided: Feb 9, 2023 after 28 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: 8 generations back to DEN070003 (2008). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201035: ETHICON Linx Esophagus Sizing Tool, Torax Medical, Inc. (2020) Summary page 4.

## 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/K230089
Methodology: https://510kreport.com/methodology