Cleared Traditional

K201035 - ETHICON Linx Esophagus Sizing Tool (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201035 · Torax Medical, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jul 2020
Decision
80d
Days
Class 2
Risk

K201035 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 July 9, 2020 after a review of 80 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Torax Medical, Inc. devices

Submission Details

510(k) Number K201035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2020
Decision Date July 09, 2020
Days to Decision 80 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 130d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.