Cleared Traditional

GORE VIABIL Short Wire Biliary Endoprosthesis (K170740) - FDA 510(k) Clearance

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

K170740 · W.L. Gore & Associates, Inc. · Gastroenterology & Urology device
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May 2017
Decision
59d
Days
Class 2
Risk

K170740 is an FDA 510(k) clearance for the GORE VIABIL Short Wire Biliary Endoprosthesis. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Elkton, US). The FDA issued a Cleared decision on May 8, 2017 after a review of 59 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 W.L. Gore & Associates, Inc. devices

Submission Details

510(k) Number K170740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received March 10, 2017
Decision Date May 08, 2017
Days to Decision 59 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
71d faster than avg
Panel avg: 130d · This submission: 59d
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 180
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K170740.
CRE RX Biliary Balloon Dilatation Catheter
K172520 · Boston Scientific Corporation · Oct 2017
Epic Biliary Endoscopic Stent System
K171809 · Boston Scientific Corporation · Aug 2017
Quantum TTC Biliary Balloon Dilator
K171223 · Wilson-Cook Medical, Inc. · Jun 2017
AngioDynamics Total Abscession Biliary Drainage Catheter
K170743 · AngioDynamics, Inc. · Mar 2017
Express SD Biliary Monorail Premounted Stent System
K162404 · Boston Scientific Corporation · Oct 2016
WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary
K152853 · Boston Scientific Corp · Nov 2015