Cleared Special

K032137 - PRECISE RX NITINOL STENT TRANSHEPATIC B...

K032137 is an FDA 510(k) clearance for PRECISE RX NITINOL STENT TRANSHEPATIC B..., manufactured by Cordis Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Special 510(k) pathway after a 68-day FDA review.

K032137 · Cordis Corp. · Gastroenterology & Urology device
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Sep 2003
Decision
68d
Days
Class 2
Risk

K032137 is an FDA 510(k) clearance for the PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Cordis Corp. (Miami Lakes, US). The FDA issued a Cleared decision on September 17, 2003 after a review of 68 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 Cordis Corp. devices

FDA 510(k) Submission Details - K032137

510(k) Number K032137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received July 11, 2003
Decision Date September 17, 2003
Days to Decision 68 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 130d · This submission: 68d
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 317
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K032137.
ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM
K033393 · Guidant Corp. · Nov 2003
PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
K032580 · Ev3, Inc. · Oct 2003
SENTINOL NITINOL BILLARY STENT SYSTEM
K032025 · Boston Scientific Corp · Sep 2003
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K032457 · Cordis Corp. · Sep 2003
MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM AND EXPRESS BILIARY LD UNMOUNTED STENT
K032360 · Boston Scientific Corp · Aug 2003
PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION
K032206 · Ev3, Inc. · Aug 2003