Not Cleared Direct

DEN230019 - AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent) (FDA 510(k) Clearance)

Also includes:
AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm Stent)

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

DEN230019 · Boston Scientific Corporation · Gastroenterology & Urology device
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Aug 2023
Decision
144d
Days
Class 2
Risk

DEN230019 is an FDA 510(k) submission (not cleared) for the AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent). Classified as Gallbladder Drainage Stent And Delivery System (product code QXH), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Not Cleared (DENG) decision on August 18, 2023 after a review of 144 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5016 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Gastroenterology & Urology review framework.

View all Boston Scientific Corporation devices

Submission Details

510(k) Number DEN230019 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 27, 2023
Decision Date August 18, 2023
Days to Decision 144 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
14d slower than avg
Panel avg: 130d · This submission: 144d
Pathway characteristics

Device Classification

Product Code QXH Gallbladder Drainage Stent And Delivery System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5016
Definition A Gallbladder Drainage Stent Is A Prescription Device Intended To Facilitate Transgastric Or Transduodenal Endoscopic Drainage Of The Gallbladder. This Device May Also Include A Delivery System.
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.