Cleared Traditional

K143645 - EsophyX® Z Fastener Delivery Device (FDA 510(k) Clearance)

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

K143645 · Endogastric Solutions, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
72d
Days
Class 2
Risk

K143645 is an FDA 510(k) clearance for the EsophyX® Z Fastener Delivery Device. Classified as Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd) (product code ODE), Class II - Special Controls.

Submitted by Endogastric Solutions, Inc. (Redmond, US). The FDA issued a Cleared decision on March 4, 2015 after a review of 72 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. 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 Endogastric Solutions, Inc. devices

Submission Details

510(k) Number K143645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2014
Decision Date March 04, 2015
Days to Decision 72 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
58d faster than avg
Panel avg: 130d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.