Cleared Special

K052539 - COOK FORMULA 418 BILIARY STENT SYSTEM

K052539 is an FDA 510(k) clearance for COOK FORMULA 418 BILIARY STENT SYSTEM, manufactured by Cook, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Special 510(k) pathway after a 85-day FDA review.

K052539 · Cook, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
85d
Days
Class 2
Risk

K052539 is an FDA 510(k) clearance for the COOK FORMULA 418 BILIARY STENT SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on December 9, 2005 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. 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.

FDA 510(k) Submission Details - K052539

510(k) Number K052539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2005
Decision Date December 09, 2005
Days to Decision 85 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
46d faster than avg
Panel avg: 131d · This submission: 85d
Pathway characteristics
Modification to existing cleared device.

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 477
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K052539.
RX HERCULINK ELITE BILIARY STENT SYSTEM
K053454 · Guidant Corporation · Mar 2006
LIFESTENT FLEXSTART BILIARY STENT SYSTEM
K053404 · Edwards Lifesciences, LLC · Dec 2005
GP GENERAL PURPOSE DRAINAGE CATHETER
K053245 · Uresil, LLC · Dec 2005
BARD CONFORMEXX BILIARY STENT WITH THE PERFORMAXX GRIP
K052114 · Bard Peripheral Vascular, Inc. · Aug 2005
MODIFICATION TO: LIFESTENT VALEO BILIARY STENT SYSTEM
K052132 · Edwards Lifesciences, LLC · Aug 2005
FORMULA 418 BILIARY STENT
K051785 · Cook, Inc. · Aug 2005
K052539 · COOK FORMULA 418 BILIARY STENT SYSTEM
Download PDF FDA Summary Cook, Inc.