Cleared Traditional

K162404 - Express SD Biliary Monorail Premounted ...

K162404 is the FDA 510(k) clearance for Express SD Biliary Monorail Premounted ... by Boston Scientific Corporation. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K162404 · Boston Scientific Corporation · Gastroenterology & Urology device
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Oct 2016
Decision
44d
Days
Class 2
Risk

K162404 is an FDA 510(k) clearance for the Express SD Biliary Monorail Premounted Stent System. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on October 12, 2016 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - 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 K162404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2016
Decision Date October 12, 2016
Days to Decision 44 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
86d faster than avg
Panel avg: 130d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FGE Stents, Drains And Dilators For The Biliary Ducts
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
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 - FGE Stents, Drains And Dilators For The Biliary Ducts

All 305
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K162404.
Zilver 518TM Biliary Stent
K163169 · Cook Ireland, Ltd. · Feb 2017
Reliant Multistage Dilatation Balloon Catheter
K162226 · Micro-Tech (Nanjing) Co., Ltd. · Jan 2017
Zilver 635 Biliary Stent
K163018 · Cook Ireland, Ltd. · Dec 2016
Soehendra Stent Retriever
K161203 · Wilson-Cook Medical, Inc. · May 2016
WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary
K152853 · Boston Scientific Corp · Nov 2015
Elation Wireguided Balloon Dilation Catheter
K151925 · Merit Medical Systems, Inc. · Nov 2015