Cleared Special

ENDOMAXX FULLY COVERED ESOPHAGEAL STENT (K111611) - FDA 510(k) Clearance

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

K111611 · Merit Medical Systems, Inc. · Gastroenterology & Urology device
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Jul 2011
Decision
50d
Days
Class 2
Risk

K111611 is an FDA 510(k) clearance for the ENDOMAXX FULLY COVERED ESOPHAGEAL STENT. Classified as Prosthesis, Esophageal (product code ESW), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on July 29, 2011 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.3610 - 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 Merit Medical Systems, Inc. devices

Submission Details

510(k) Number K111611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2011
Decision Date July 29, 2011
Days to Decision 50 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
80d faster than avg
Panel avg: 130d · This submission: 50d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code ESW Prosthesis, Esophageal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3610
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.

Regulatory Peers - ESW Prosthesis, Esophageal

All 58
Devices cleared under the same product code (ESW) and FDA review panel - the closest regulatory comparables to K111611.
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Ultraflex Esophageal NG Stent System
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Agile Esophageal Stent System
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Esophageal TTS Stent
K240522 · Taewoong Medical · Mar 2024