Cleared Special

K111611 - ENDOMAXX FULLY COVERED ESOPHAGEAL STENT

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

K111611 · Merit Medical Systems, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K111611

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
81d faster than avg
Panel avg: 131d · This submission: 50d
Pathway characteristics
Modification to existing cleared device.

ESW Device Classification - Class 2, Special Controls

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 59
Devices cleared under the same product code (ESW) and FDA review panel - the closest regulatory comparables to K111611.
ESOPHAGEAL TTS STENT
K123205 · Taewoong Medical Co., Ltd. · Oct 2013
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K120983 · Boston Scientific Corporation · May 2012
ESOPHAGEAL TTS STENT
K113551 · Taewoong Medical Co., Ltd. · Feb 2012
EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-E
K093619 · Cook Ireland, Ltd. · Jun 2010
HANAROSTENT ESOPHAGUS (CCC)
K093537 · M.I. Tech Co., Ltd. · Jun 2010
BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR
K092144 · Endochoice, Inc. · Feb 2010
K111611 · ENDOMAXX FULLY COVERED ESOPHAGEAL STENT
Download PDF FDA Summary Merit Medical Systems…