Cleared Traditional

K063481 - MODIFICATION TO RX HERCULINK ELITE BILI...

K063481 is the FDA 510(k) clearance for MODIFICATION TO RX HERCULINK ELITE BILI... by Abbott Vascular, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K063481 · Abbott Vascular, Inc. · Gastroenterology & Urology device
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Sep 2007
Decision
301d
Days
Class 2
Risk

K063481 is an FDA 510(k) clearance for the MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Abbott Vascular, Inc. (Santa Clara, US). The FDA issued a Cleared decision on September 14, 2007 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Abbott Vascular, Inc. devices

Submission Details

510(k) Number K063481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received November 17, 2006
Decision Date September 14, 2007
Days to Decision 301 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
171d slower than avg
Panel avg: 130d · This submission: 301d
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 299
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K063481.
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
WELLFLEX BILIARY RX STENT SYSTEM
K061231 · Boston Scientific Corp · Sep 2006
PRIMUS GPS BILIARY STENT SYSTEM
K061566 · Ev3, Inc. · Aug 2006
LIFESTENT TURBO BILIARY STENT SYSTEM
K061235 · Edwards Lifesciences, LLC · Jun 2006