Cleared Special

K230089 - ETHICON LINX® Esophagus Sizing Tool (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K230089 · Torax Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2023
Decision
28d
Days
Class 2
Risk

K230089 is an FDA 510(k) clearance for the ETHICON LINX® Esophagus Sizing Tool. Classified as Laparoscopic Accessories, Esophageal Sizing (product code QJN), Class II - Special Controls.

Submitted by Torax Medical, Inc. (Shoreview, US). The FDA issued a Cleared decision on February 9, 2023 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5360 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Torax Medical, Inc. devices

Submission Details

510(k) Number K230089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2023
Decision Date February 09, 2023
Days to Decision 28 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QJN Laparoscopic Accessories, Esophageal Sizing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5360
Definition To Laparoscopically Measure An Extraluminal Dimensional Parameter Of A Gastrointestinal Organ.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.