Cleared Special

K040151 - OASIS BILIARY STENT INTRODUCTION SYSTEM

K040151 is an FDA 510(k) clearance for OASIS BILIARY STENT INTRODUCTION SYSTEM, manufactured by Wilson-Cook Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Special 510(k) pathway after a 28-day FDA review.

K040151 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
28d
Days
Class 2
Risk

K040151 is an FDA 510(k) clearance for the OASIS BILIARY STENT INTRODUCTION SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on February 20, 2004 after a review of 28 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 - K040151

510(k) Number K040151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2004
Decision Date February 20, 2004
Days to Decision 28 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
103d faster than avg
Panel avg: 131d · This submission: 28d
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 K040151.
BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM
K040027 · Boston Scientific · Mar 2004
ZILVER 635 BILIARY STENT
K040505 · Cook, Inc. · Mar 2004
LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS
K040550 · Orbus Medical Technologies · Mar 2004
WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM
K033909 · Abbott Laboratories · Feb 2004
DURAMAX .018 BILIARY STENT SYSTEM
K032436 · Avantec Vascular Corp. · Feb 2004
BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM
K033497 · C.R. Bard, Inc. · Feb 2004
K040151 · OASIS BILIARY STENT INTRODUCTION SYSTEM
Download PDF FDA Summary Wilson-Cook Medical, …