Not Cleared Post-NSE

AXIOS STENT AND DELIVERY SYSTEM (DEN130007) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN130007 · Xlumena, Inc. · Gastroenterology & Urology device
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Dec 2013
Decision
302d
Days
Class 2
Risk

DEN130007 is an FDA 510(k) submission (not cleared) for the AXIOS STENT AND DELIVERY SYSTEM. Classified as Pancreatic Stent, Covered, Metallic, Removable (product code PCU), Class II - Special Controls.

Submitted by Xlumena, Inc. (Mountain View, US). The FDA issued a Not Cleared (DENG) decision on December 18, 2013 after a review of 302 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5015 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 302 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Xlumena, Inc. devices

Submission Details

510(k) Number DEN130007 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received February 19, 2013
Decision Date December 18, 2013
Days to Decision 302 days
Submission Type Post-NSE
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
172d slower than avg
Panel avg: 130d · This submission: 302d
Pathway characteristics

Device Classification

Product Code PCU Pancreatic Stent, Covered, Metallic, Removable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5015
Definition To Facilitate Transmural Endoscopic Drainage Of Pancreatic Pseudocysts
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 - PCU Pancreatic Stent, Covered, Metallic, Removable

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