Cleared Traditional

K083627 - WALLFLEX BILIARY RX FULLY-COVERED STENT...

K083627 is the FDA 510(k) clearance for WALLFLEX BILIARY RX FULLY-COVERED STENT... by Boston Scientific Corporation. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K083627 · Boston Scientific Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
120d
Days
Class 2
Risk

K083627 is an FDA 510(k) clearance for the WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M0.... Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on April 7, 2009 after a review of 120 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 Corporation devices

Submission Details

510(k) Number K083627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received December 08, 2008
Decision Date April 07, 2009
Days to Decision 120 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
10d faster than avg
Panel avg: 130d · This submission: 120d
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
NCT00433771 Completed Interventional Industry-sponsored

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

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

74
Patients (actual)
10
Sites
Treatment
Purpose
Open label
Masking
Condition studied Cholestasis, Extrahepatic
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Bret Petersen, MD
Sponsor Boston Scientific Corporation (industry)
Started 2007-03-01 → Primary completion 2008-05-01
Primary outcome
Adequate Clinical Palliation of the Biliary Obstruction
Secondary outcome
Technical Success
View full study on ClinicalTrials.gov

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

All 305
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K083627.
ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC
K093947 · Merit Medical Systems, Inc. · Jan 2010
MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS
K093392 · Navilyst Medical, Inc. · Dec 2009
WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM
K083374 · Boston Scientific Corp · 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
MODIFICATION TO ZILVER 635 BILIARY STENT
K080037 · Cook, Inc. · Aug 2008