Cleared Special

K152572 - AXIOS Stent and Delivery System (FDA 510(k) Clearance)

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

K152572 · Boston Scientific Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
27d
Days
Class 2
Risk

K152572 is an FDA 510(k) clearance for the AXIOS Stent and Delivery System. Classified as Pancreatic Stent, Covered, Metallic, Removable (product code PCU), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Mountain View, US). The FDA issued a Cleared decision on October 6, 2015 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5015 - 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.

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Submission Details

510(k) Number K152572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2015
Decision Date October 06, 2015
Days to Decision 27 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
103d faster than avg
Panel avg: 130d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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.