Cleared Traditional

K153088 - AXIOS Stent with Delivery System

K153088 is the FDA 510(k) clearance for AXIOS Stent with Delivery System by Boston Scientific Corporation. It is a Class 2 Gastroenterology & Urology device (product code PCU) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K153088 · Boston Scientific Corporation · Gastroenterology & Urology device
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Dec 2015
Decision
46d
Days
Class 2
Risk

K153088 is an FDA 510(k) clearance for the AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced D.... Classified as Pancreatic Stent, Covered, Metallic, Removable (product code PCU), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on December 11, 2015 after a review of 46 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boston Scientific Corporation devices

Submission Details

510(k) Number K153088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2015
Decision Date December 11, 2015
Days to Decision 46 days
Submission Type Traditional
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
84d faster than avg
Panel avg: 130d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

All 8
Devices cleared under the same product code (PCU) and FDA review panel - the closest regulatory comparables to K153088.
AXIOS Stent and Electrocautery Enhanced Delivery System
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AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System
K181905 · Boston Scientific Corporation · Mar 2019
AXIOS Stent and Electrocautery Enhanced Delivery System
K163272 · Boston Scientific Corporation · Feb 2017
AXIOS Stent and Delivery System
K152572 · Boston Scientific Corporation · Oct 2015
AXIOS Stent with Electrocautery Enhanced Delivery System
K150692 · Boston Scientific Corp · Aug 2015