Cleared Special

K111611 - ENDOMAXX FULLY COVERED ESOPHAGEAL STENT

K111611 is the FDA 510(k) clearance for ENDOMAXX FULLY COVERED ESOPHAGEAL STENT by Merit Medical Systems, Inc.. It is a Class 2 Gastroenterology & Urology device (product code ESW) cleared through the Special 510(k) pathway after a 50-day FDA review.

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
Combination Product No
PCCP Authorized No
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 32
Devices cleared under the same product code (ESW) and FDA review panel - the closest regulatory comparables to K111611.
Esophageal Stent System
K172813 · Micro-Tech (Nanjing) Co., Ltd. · May 2018
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K130004 · Boston Scientific Corporation · Dec 2013
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K120983 · Boston Scientific Corporation · May 2012
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K091816 · Boston Scientific Corporation · Jul 2009
WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730
K091510 · Boston Scientific Corporation · Jun 2009
POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330
K080332 · Boston Scientific Corporation · Sep 2008