← Back to catalogue

Ethicon Linx Esophagus Sizing Tool

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K201035

by Torax Medical, Inc.

Identifiers

510(k) Number
K201035 FDA 510(k)
FDA Product Code
QJN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5360 FDA 510(k)
Regulation Number
876.5360 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Ethicon Linx Esophagus Sizing Tool is a laparoscopic accessory classified as an esophageal sizing device. It is designed to measure the circumference of the lower esophageal sphincter to determine the appropriate size of the LINX Reflux Management System implant.

This single-use device is intended for use in surgical settings by trained professionals during laparoscopic procedures. Supplied sterile, it is regulated under FDA 510(k) clearance (K201035) and the Medical Device Directive (MDD), falling under product code QJN for Class II devices in gastroenterology and urology. Storage and handling must comply with manufacturer guidelines to maintain sterility and functionality.

Frequently asked questions

What is the primary purpose of the Ethicon Linx Esophagus Sizing Tool in a surgical setting?

The Ethicon Linx Esophagus Sizing Tool is specifically designed to measure the circumference of the lower esophageal sphincter during laparoscopic procedures. This measurement helps determine the correct size of the LINX Reflux Management System implant, ensuring a precise fit for the patient’s anatomy.

Is the Ethicon Linx Esophagus Sizing Tool reusable or intended for single-use only?

The device is explicitly labeled as single-use only. It is supplied sterile and must be discarded after one use to maintain safety and sterility standards, as outlined by the manufacturer’s guidelines.

How should the Ethicon Linx Esophagus Sizing Tool be stored to preserve its integrity?

The tool must be stored and handled according to the manufacturer’s instructions to ensure sterility and functionality. Since it is supplied sterile, proper storage conditions—such as avoiding contamination or exposure to extreme temperatures—are critical to maintaining its readiness for use.

What regulatory pathways does the Ethicon Linx Esophagus Sizing Tool follow, and how does this affect its use?

The device is cleared under the FDA’s 510(k) pathway (K201035) and complies with the Medical Device Directive (MDD). It is classified as a Class II device under product code QJN for gastroenterology and urology applications, meaning it undergoes rigorous review to ensure safety and performance before clinical use.

Are there different sizes or models of the Ethicon Linx Esophagus Sizing Tool, or is it a one-size-fits-all tool?

The device data does not specify multiple sizes or models, implying it is likely designed as a standardized tool for measuring the lower esophageal sphincter circumference. However, the actual sizing options may correlate directly to the LINX implant sizes, ensuring compatibility. Always verify with the manufacturer for precise sizing details.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Ethicon Homepage | Ethicon - Johnson & Johnson Medical Devices, ETHICON LINX® Esophagus Sizing Tool (K230089) - Innolitics, K230089 FDA 510 (k) - ETHICON LINX Esophagus Sizing Tool, AccessGUDID - DEVICE: ETHICON Linx Esophagus Sizing Tool (10855106005438)

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Torax Medical, Inc.

Sources (2)

  • FDA 510(k) K201035 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026