Cleared Traditional

K061231 - WELLFLEX BILIARY RX STENT SYSTEM

K061231 is the FDA 510(k) clearance for WELLFLEX BILIARY RX STENT SYSTEM by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K061231 · Boston Scientific Corp · Gastroenterology & Urology device
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Sep 2006
Decision
122d
Days
Class 2
Risk

K061231 is an FDA 510(k) clearance for the WELLFLEX BILIARY RX STENT SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Boston Scientific Corp (Marlboro, US). The FDA issued a Cleared decision on September 1, 2006 after a review of 122 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Boston Scientific Corp devices

Submission Details

510(k) Number K061231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received May 02, 2006
Decision Date September 01, 2006
Days to Decision 122 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
8d faster than avg
Panel avg: 130d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 298
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K061231.
SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB
K062798 · Cordis Corp. · Feb 2008
RESOLVE BILIARY DRAINAGE CATHETER
K063733 · Merit Medical Systems, Inc. · Nov 2007
COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM
K062264 · Medtronic Vascular · Nov 2007
PRIMUS GPS BILIARY STENT SYSTEM
K061566 · Ev3, Inc. · Aug 2006
LIFESTENT TURBO BILIARY STENT SYSTEM
K061235 · Edwards Lifesciences, LLC · Jun 2006
PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX
K060877 · Cordis Corp. · Apr 2006