Cleared Traditional

K030559 - RUSCH POLYFLEX STENT FOR THE ESOPHAGUS ...

K030559 is the FDA 510(k) clearance for RUSCH POLYFLEX STENT FOR THE ESOPHAGUS ... by Rusch Intl.. It is a Class 2 Gastroenterology & Urology device (product code ESW) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K030559 · Rusch Intl. · Gastroenterology & Urology device
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Jun 2003
Decision
129d
Days
Class 2
Risk

K030559 is an FDA 510(k) clearance for the RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM. Classified as Prosthesis, Esophageal (product code ESW), Class II - Special Controls.

Submitted by Rusch Intl. (Jaffrey, US). The FDA issued a Cleared decision on June 30, 2003 after a review of 129 days - within the typical 510(k) review window.

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 Rusch Intl. devices

Submission Details

510(k) Number K030559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2003
Decision Date June 30, 2003
Days to Decision 129 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
1d faster than avg
Panel avg: 130d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 37
Devices cleared under the same product code (ESW) and FDA review panel - the closest regulatory comparables to K030559.
POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330
K080332 · Boston Scientific Corporation · Sep 2008
WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM
K073266 · Boston Scientific Corp · Feb 2008
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K032930 · Boston Scientific Corp · Oct 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
RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM
K010068 · Rusch Intl. · Feb 2001