Cleared Traditional

WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM (K033909) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K033909 · Abbott Laboratories · Gastroenterology & Urology device
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Feb 2004
Decision
62d
Days
Class 2
Risk

K033909 is an FDA 510(k) clearance for the WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Abbott Laboratories (Redwood, US). The FDA issued a Cleared decision on February 17, 2004 after a review of 62 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Abbott Laboratories devices

Submission Details

510(k) Number K033909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received December 17, 2003
Decision Date February 17, 2004
Days to Decision 62 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
68d faster than avg
Panel avg: 130d · This submission: 62d
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 212
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K033909.
XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008, EX8S4008, EX8S6008
K040667 · Abbott Laboratories · Apr 2004
ZILVER 635 BILIARY STENT
K040505 · Cook, Inc. · Mar 2004
OASIS BILIARY STENT INTRODUCTION SYSTEM
K040151 · Wilson-Cook Medical, Inc. · Feb 2004
BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM
K033497 · C.R. Bard, Inc. · Feb 2004
CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM
K033394 · Cordis Corp. · Dec 2003
ZILVER 518 BILIARY STENT
K033348 · Cook, Inc. · Dec 2003