Cleared Special

K142113 - ESOPHYX2 HD (FDA 510(k) Clearance)

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

K142113 · Endogastric Solutions, Inc. · Gastroenterology & Urology device
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Sep 2014
Decision
57d
Days
Class 2
Risk

K142113 is an FDA 510(k) clearance for the ESOPHYX2 HD. Classified as Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd) (product code ODE), Class II - Special Controls.

Submitted by Endogastric Solutions, Inc. (Gardnerville, US). The FDA issued a Cleared decision on September 30, 2014 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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 Endogastric Solutions, Inc. devices

Submission Details

510(k) Number K142113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2014
Decision Date September 30, 2014
Days to Decision 57 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 130d · This submission: 57d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code ODE Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Treat The Symptoms Of Chronic Gastroesophageal Reflux Disease (gerd), Either By Approximating Tissue With Sutures Or Plicating Tissue With An Implant.
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.