Cleared Special

K130484 - MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K130484 · Boston Scientific Corp · Gastroenterology & Urology device
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Aug 2013
Decision
165d
Days
Class 2
Risk

K130484 is an FDA 510(k) clearance for the MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER. 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 August 9, 2013 after a review of 165 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K130484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2013
Decision Date August 09, 2013
Days to Decision 165 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 130d · This submission: 165d
Pathway characteristics
Modification to existing cleared device.

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 473
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