Cleared Special

K182980 - Zilver 518 Biliary Stent

K182980 is the FDA 510(k) clearance for Zilver 518 Biliary Stent by Cook Ireland, Ltd.. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Special 510(k) pathway after a 18-day FDA review.

K182980 · Cook Ireland, Ltd. · Gastroenterology & Urology device
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Nov 2018
Decision
18d
Days
Class 2
Risk

K182980 is an FDA 510(k) clearance for the Zilver 518 Biliary Stent, 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 November 16, 2018 after a review of 18 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cook Ireland, Ltd. devices

Submission Details

510(k) Number K182980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received October 29, 2018
Decision Date November 16, 2018
Days to Decision 18 days
Submission Type Special
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
112d faster than avg
Panel avg: 130d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

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 300
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K182980.
EndoGI Biliary Stent System
K193600 · Endogi Medical, Ltd. · Jun 2020
ConvertX Biliary Stent System
K181669 · Brightwater Medical · Mar 2019
HANAROSTENT FASTTM Biliary (NNN)
K183396 · M.I. Tech Co., Ltd. · Feb 2019
Reliant(TM) Multistage Dilatation Balloon Catheter
K180418 · Micro-Tech (Nanjing) Co., Ltd. · Oct 2018
Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set
K180868 · Cook Ireland · Jul 2018
Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets
K173035 · Cook Incorporated · May 2018