Cleared Traditional

K181905 - AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K181905 · Boston Scientific Corporation · Gastroenterology & Urology device
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Mar 2019
Decision
252d
Days
Class 2
Risk

K181905 is an FDA 510(k) clearance for the AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Deli.... 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 March 25, 2019 after a review of 252 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K181905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2018
Decision Date March 25, 2019
Days to Decision 252 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 130d · This submission: 252d
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.