Cleared Traditional

K163169 - Zilver 518TM Biliary Stent

Also marketed or referenced as:
Zilver 635TM Biliary Stent

K163169 is an FDA 510(k) clearance for Zilver 518TM Biliary Stent, manufactured by Cook Ireland, Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K163169 · Cook Ireland, Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
85d
Days
Class 2
Risk

K163169 is an FDA 510(k) clearance for the Zilver 518TM Biliary Stent. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Cook Ireland, Ltd. (Limerick, IE). The FDA issued a Cleared decision on February 7, 2017 after a review of 85 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 Cook Ireland, Ltd. devices

FDA 510(k) Submission Details - K163169

510(k) Number K163169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received November 14, 2016
Decision Date February 07, 2017
Days to Decision 85 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
46d faster than avg
Panel avg: 131d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGE Device Classification - Class 2, Special Controls

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 395
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K163169.
Quantum TTC Biliary Balloon Dilator
K171223 · Wilson-Cook Medical, Inc. · Jun 2017
GORE VIABIL Short Wire Biliary Endoprosthesis
K170740 · W.L. Gore & Associates, Inc. · May 2017
AngioDynamics Total Abscession Biliary Drainage Catheter
K170743 · AngioDynamics, Inc. · Mar 2017
Reliant Multistage Dilatation Balloon Catheter
K162226 · Micro-Tech (Nanjing) Co., Ltd. · Jan 2017
Zilver 635 Biliary Stent
K163018 · Cook Ireland, Ltd. · Dec 2016
Express SD Biliary Monorail Premounted Stent System
K162404 · Boston Scientific Corporation · Oct 2016