Not Cleared Direct

WallFlex Biliary RX Fully Covered Stent System RMV (DEN150040) - FDA 510(k) Clearance

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

DEN150040 · Boston Scientific · Gastroenterology & Urology device
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Jun 2016
Decision
280d
Days
Class 2
Risk

DEN150040 is an FDA 510(k) submission (not cleared) for the WallFlex Biliary RX Fully Covered Stent System RMV. Classified as Biliary Stent System For Benign Strictures (product code PNB), Class II - Special Controls.

Submitted by Boston Scientific (Marlboro, US). The FDA issued a Not Cleared (DENG) decision on June 3, 2016 after a review of 280 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5011 - 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. Elevated predicate reliance profile. With 280 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.

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Submission Details

510(k) Number DEN150040 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 28, 2015
Decision Date June 03, 2016
Days to Decision 280 days
Submission Type Direct
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 130d · This submission: 280d
Pathway characteristics

Device Classification

Product Code PNB Biliary Stent System For Benign Strictures
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5011
Definition A Benign Stricture Biliary Stent System Is A Prescription Device Intended For Treatment Of Benign Biliary Strictures. Stents Are Intended To Be Left Indwelling For A Limited Amount Of Time And Subsequently Removed. The Device Consists Of A Metal Stent And A Delivery System Intended To Place The Stent In The Biliary Ducts.
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.