Cleared Special

K091816 - ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM

K091816 is the FDA 510(k) clearance for ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM by Boston Scientific Corporation. It is a Class 2 Gastroenterology & Urology device (product code ESW) cleared through the Special 510(k) pathway after a 13-day FDA review.

K091816 · Boston Scientific Corporation · Gastroenterology & Urology device
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Jul 2009
Decision
13d
Days
Class 2
Risk

K091816 is an FDA 510(k) clearance for the ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM. Classified as Prosthesis, Esophageal (product code ESW), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on July 1, 2009 after a review of 13 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 Boston Scientific Corporation devices

Submission Details

510(k) Number K091816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2009
Decision Date July 01, 2009
Days to Decision 13 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
117d faster than avg
Panel avg: 130d · This submission: 13d
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 40
Devices cleared under the same product code (ESW) and FDA review panel - the closest regulatory comparables to K091816.
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K120983 · Boston Scientific Corporation · May 2012
ENDOMAXX FULLY COVERED ESOPHAGEAL STENT
K111611 · Merit Medical Systems, Inc. · Jul 2011
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
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
EVOLUTION ESOPHAGEAL STENT SYSTEM
K080359 · Cook Ireland, Ltd. · May 2008