Cleared Traditional

K080332 - POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330

K080332 is an FDA 510(k) clearance for POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, manufactured by Boston Scientific Corporation. The device is a Class 2 Gastroenterology & Urology device with product code ESW cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K080332 · Boston Scientific Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
211d
Days
Class 2
Risk

K080332 is an FDA 510(k) clearance for the POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514.... 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 September 5, 2008 after a review of 211 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.3610 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Boston Scientific Corporation devices

FDA 510(k) Submission Details - K080332

510(k) Number K080332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2008
Decision Date September 05, 2008
Days to Decision 211 days
Submission Type Traditional
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 slower than avg
Panel avg: 131d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 53
Devices cleared under the same product code (ESW) and FDA review panel - the closest regulatory comparables to K080332.
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
NITI-S ESOPHAGEAL STENT
K080782 · Taewoong Medical Co., Ltd. · Jan 2009
EVOLUTION ESOPHAGEAL STENT SYSTEM
K080359 · Cook Ireland, Ltd. · May 2008
WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM
K073266 · Boston Scientific Corp · Feb 2008
ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM
K060239 · Alveolus, Inc. · Mar 2006