Cleared Special

K140561 - AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT)

K140561 is an FDA 510(k) clearance for AXIOS STENT AND DELIVERY SYSTEM (WITH 1..., manufactured by Xlumena, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code PCU cleared through the Special 510(k) pathway after a 49-day FDA review.

K140561 · Xlumena, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
49d
Days
Class 2
Risk

K140561 is an FDA 510(k) clearance for the AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELI.... 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 Cleared decision on April 23, 2014 after a review of 49 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.

FDA 510(k) Submission Details - K140561

510(k) Number K140561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2014
Decision Date April 23, 2014
Days to Decision 49 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 131d · This submission: 49d
Pathway characteristics
Modification to existing cleared device.

PCU Device Classification - Class 2, Special Controls

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

All 10
Devices cleared under the same product code (PCU) and FDA review panel - the closest regulatory comparables to K140561.
AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System
K153088 · Boston Scientific Corporation · Dec 2015
AXIOS Stent and Delivery System
K152572 · Boston Scientific Corporation · Oct 2015
AXIOS Stent with Electrocautery Enhanced Delivery System
K150692 · Boston Scientific Corp · Aug 2015
AXIOS STENT AND DELIVERY SYSTEM
DEN130007 · Xlumena, Inc. · Dec 2013
K140561 · AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT)
Download PDF FDA Summary Xlumena, Inc.