Cleared Special

K080838 - ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM

K080838 is an FDA 510(k) clearance for ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM, manufactured by Alveolus, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code ESW cleared through the Special 510(k) pathway after a 30-day FDA review.

K080838 · Alveolus, Inc. · Gastroenterology & Urology device
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Apr 2008
Decision
30d
Days
Class 2
Risk

K080838 is an FDA 510(k) clearance for the ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM. Classified as Prosthesis, Esophageal (product code ESW), Class II - Special Controls.

Submitted by Alveolus, Inc. (Charlotte, US). The FDA issued a Cleared decision on April 24, 2008 after a review of 30 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 Alveolus, Inc. devices

FDA 510(k) Submission Details - K080838

510(k) Number K080838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2008
Decision Date April 24, 2008
Days to Decision 30 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 130d · This submission: 30d
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 42
Devices cleared under the same product code (ESW) and FDA review panel - the closest regulatory comparables to K080838.
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
WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM
K073266 · Boston Scientific Corp · Feb 2008
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K032930 · Boston Scientific Corp · Oct 2003
RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM
K030559 · Rusch Intl. · Jun 2003