Cleared Abbreviated

K010068 - RUSCH POLYFLEX STENT FOR THE ESOPHAGUS ...

K010068 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 Abbreviated 510(k) pathway after a 31-day FDA review.

K010068 · Rusch Intl. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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Feb 2001
Decision
31d
Days
Class 2
Risk

K010068 is an FDA 510(k) clearance for the RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER 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 February 8, 2001 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Rusch Intl. devices

Submission Details

510(k) Number K010068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2001
Decision Date February 08, 2001
Days to Decision 31 days
Submission Type Abbreviated
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
99d faster than avg
Panel avg: 130d · This submission: 31d
Pathway characteristics
Standards-based clearance path.

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 K010068.
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
BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE
K002094 · C.R. Bard, Inc. · Oct 2000
ULTRAFLEX
K955347 · Boston Scientific Corp · Feb 1996
COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT
K945201 · Cook, Inc. · Jan 1995