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.
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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
| 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
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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