Cleared Special

K011184 - INTRASTENT DOUBLESTRUT PARAMOUNT XS BIL...

K011184 is an FDA 510(k) clearance for INTRASTENT DOUBLESTRUT PARAMOUNT XS BIL..., manufactured by Intratherapeutics, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Special 510(k) pathway after a 117-day FDA review.

K011184 · Intratherapeutics, Inc. · Gastroenterology & Urology device
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Aug 2001
Decision
117d
Days
Class 2
Risk

K011184 is an FDA 510(k) clearance for the INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Intratherapeutics, Inc. (Saint Paul, US). The FDA issued a Cleared decision on August 13, 2001 after a review of 117 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. 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.

View all Intratherapeutics, Inc. devices

FDA 510(k) Submission Details - K011184

510(k) Number K011184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received April 18, 2001
Decision Date August 13, 2001
Days to Decision 117 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
13d faster than avg
Panel avg: 130d · This submission: 117d
Pathway characteristics
Modification to existing cleared device.

FGE Device Classification - Class 2, Special Controls

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 314
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K011184.
PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM
K010411 · Cordis Corp. · Aug 2001
NIROYAL BILIARY PREMOUNTED STENT SYSTEM
K012216 · Boston Scientific Scimed, Inc. · Aug 2001
COOK ZILVER BILIARY STENT
K010242 · Cook, Inc. · Aug 2001
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
K012087 · Cordis Corp. · Aug 2001
DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
K011881 · Guidant Corp. · Jul 2001
OMNILINK .035 BILIARY STENT SYSTEM
K011506 · Guidant Corp. · Jun 2001