Cleared Special

K014136 - MODIFICATION TO PROTEGE SELF-EXPANDING ...

K014136 is an FDA 510(k) clearance for MODIFICATION TO PROTEGE SELF-EXPANDING ..., manufactured by Sulzer Intratherapeutics, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Special 510(k) pathway after a 31-day FDA review.

K014136 · Sulzer Intratherapeutics, Inc. · Gastroenterology & Urology device
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Jan 2002
Decision
31d
Days
Class 2
Risk

K014136 is an FDA 510(k) clearance for the MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY T.... Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Sulzer Intratherapeutics, Inc. (Saint Paul, US). The FDA issued a Cleared decision on January 17, 2002 after a review of 31 days - a notably fast clearance 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sulzer Intratherapeutics, Inc. devices

FDA 510(k) Submission Details - K014136

510(k) Number K014136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received December 17, 2001
Decision Date January 17, 2002
Days to Decision 31 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
99d faster than avg
Panel avg: 130d · This submission: 31d
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 K014136.
BARD LUMINEXX 6 FR BILIARY STENT AND DELIVERY SYSTEM
K020682 · C.R. Bard, Inc. · Apr 2002
SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K020052 · Cordis Corp. · Feb 2002
MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
K014184 · Guidant Corp. · Jan 2002
DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM
K014007 · Guidant Corp. · Jan 2002
ULTRA-THIN SDS BALLOON DILATATION CATHETER
K011909 · Boston Scientific Corp · Nov 2001
FANELLI BILIARY STENT
K010601 · Cook, Inc. · Nov 2001