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.
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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
| 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