Cleared Special

K023243 - MODIFICATION TO PROTEGE SELF-EXPANDING ...

K023243 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 74-day FDA review.

K023243 · Sulzer Intratherapeutics, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Dec 2002
Decision
74d
Days
Class 2
Risk

K023243 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 December 13, 2002 after a review of 74 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 - K023243

510(k) Number K023243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2002
Decision Date December 13, 2002
Days to Decision 74 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
56d faster than avg
Panel avg: 130d · This submission: 74d
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 K023243.
MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
K024048 · Boston Scientific Scimed, Inc. · Jan 2003
BARD CONFORMEXX BILIARY STENT AND DELIVERY SYSTEM
K021994 · C.R. Bard, Inc. · Jan 2003
VIABIL BILIARY ENDOPROSTHESIS
K014215 · W.L. Gore & Associates, Inc. · Dec 2002
BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
K021630 · Boston Scientific Corp · Oct 2002
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K023217 · Cordis Corp. · Oct 2002
SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K021898 · Cordis Corp. · Aug 2002