Cleared Special

K032930 - ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM

K032930 is an FDA 510(k) clearance for ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM, manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code ESW cleared through the Special 510(k) pathway after a 31-day FDA review.

K032930 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
31d
Days
Class 2
Risk

K032930 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 Corp (Natick,, US). The FDA issued a Cleared decision on October 23, 2003 after a review of 31 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 - K032930

510(k) Number K032930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2003
Decision Date October 23, 2003
Days to Decision 31 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
100d faster than avg
Panel avg: 131d · This submission: 31d
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 K032930.
ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM
K060239 · Alveolus, Inc. · Mar 2006
ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEM
K051621 · Alveolus, Inc. · Jul 2005
NITI-S STENT & INTRODUCER, MODEL EOXXXX
K041648 · Taewoong Medical Co., Ltd. · Apr 2005
RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM
K030559 · Rusch Intl. · Jun 2003
ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE
K011591 · Wilson-Cook Medical, Inc. · Jul 2002
ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM
K012883 · Boston Scientific Corp · Oct 2001
K032930 · ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
Download PDF FDA Summary Boston Scientific Corp