Cleared Traditional

K163018 - Zilver 635 Biliary Stent

K163018 is an FDA 510(k) clearance for Zilver 635 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 53-day FDA review.

K163018 · Cook Ireland, Ltd. · Gastroenterology & Urology device
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Dec 2016
Decision
53d
Days
Class 2
Risk

K163018 is an FDA 510(k) clearance for the Zilver 635 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 December 23, 2016 after a review of 53 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 - K163018

510(k) Number K163018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received October 31, 2016
Decision Date December 23, 2016
Days to Decision 53 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
78d faster than avg
Panel avg: 131d · This submission: 53d
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 K163018.
AngioDynamics Total Abscession Biliary Drainage Catheter
K170743 · AngioDynamics, Inc. · Mar 2017
Zilver 518TM Biliary Stent
K163169 · Cook Ireland, Ltd. · Feb 2017
Reliant Multistage Dilatation Balloon Catheter
K162226 · Micro-Tech (Nanjing) Co., Ltd. · Jan 2017
Express SD Biliary Monorail Premounted Stent System
K162404 · Boston Scientific Corporation · Oct 2016
Soehendra Stent Retriever
K161203 · Wilson-Cook Medical, Inc. · May 2016
X-Suit NIR Biliary Metallic Stent
K150487 · Medinol, Ltd. · Feb 2016