Cleared Traditional

K083374 - WALLFLEX BILIARY RX PARTIALLY-COVERED S...

K083374 is the FDA 510(k) clearance for WALLFLEX BILIARY RX PARTIALLY-COVERED S... by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K083374 · Boston Scientific Corp · Gastroenterology & Urology device
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Apr 2009
Decision
160d
Days
Class 2
Risk

K083374 is an FDA 510(k) clearance for the WALLFLEX BILIARY RX PARTIALLY-COVERED 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 April 22, 2009 after a review of 160 days - an extended review 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: 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 K083374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received November 13, 2008
Decision Date April 22, 2009
Days to Decision 160 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
30d slower than avg
Panel avg: 130d · This submission: 160d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Gastroenterology & Urology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00713427 Completed Interventional Industry-sponsored

Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

A Multi-Center, Single Arm, Prospective Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

70
Patients (actual)
6
Sites
Treatment
Purpose
Open label
Masking
Condition studied Biliary Strictures Caused by Malignant Neoplasms
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Robert Walsh, M.D.
Sponsor Boston Scientific Corporation (industry)
Started 2007-07-01 → Primary completion 2008-05-01
Primary outcome
Number of Participants With Absence of Recurrent Biliary Obstruction
Secondary outcome
Number of Adverse Events Related to the Device and/or Procedure
View full study on ClinicalTrials.gov

Regulatory Peers - FGE Stents, Drains And Dilators For The Biliary Ducts

All 269
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K083374.
ADVANIX DOUBLE PIGTAIL BILIARY STENT
K101786 · Boston Scientific Corp · Jul 2010
DIRECT PERORAL CHOLANGIOSCOPY BALLOON
K101095 · Wilson-Cook Medical, Inc. · Jul 2010
ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC
K093947 · Merit Medical Systems, Inc. · Jan 2010
WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M00570520, M00570530, M00570540
K083627 · Boston Scientific Corporation · Apr 2009
CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS
K090133 · Cook, Inc. · Feb 2009
10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890
K081733 · Boston Scientific Corp · Oct 2008