Cleared Traditional

K051621 - ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT...

K051621 is an FDA 510(k) clearance for ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT..., manufactured by Alveolus, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code ESW cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K051621 · Alveolus, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jul 2005
Decision
21d
Days
Class 2
Risk

K051621 is an FDA 510(k) clearance for the ENDOVENTIONS 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 July 11, 2005 after a review of 21 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Alveolus, Inc. devices

FDA 510(k) Submission Details - K051621

510(k) Number K051621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2005
Decision Date July 11, 2005
Days to Decision 21 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 130d · This submission: 21d
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 42
Devices cleared under the same product code (ESW) and FDA review panel - the closest regulatory comparables to K051621.
POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330
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K032930 · Boston Scientific Corp · Oct 2003
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ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE
K011591 · Wilson-Cook Medical, Inc. · Jul 2002