Cleared Special

K003336 - MODIFICATION TO S.M.A.R.T NITINOL STENT...

K003336 is an FDA 510(k) clearance for MODIFICATION TO S.M.A.R.T NITINOL STENT..., 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 28-day FDA review.

K003336 · Cordis Corp. · Gastroenterology & Urology device
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Nov 2000
Decision
28d
Days
Class 2
Risk

K003336 is an FDA 510(k) clearance for the MODIFICATION TO S.M.A.R.T 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 November 22, 2000 after a review of 28 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 - K003336

510(k) Number K003336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received October 25, 2000
Decision Date November 22, 2000
Days to Decision 28 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
102d faster than avg
Panel avg: 130d · This submission: 28d
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 K003336.
BARD MEMOTHERM ENDOSCOPIC BILIARY STENT
K003186 · C.R. Bard, Inc. · Jan 2001
BARD LUMINEXX BILIARY STENT
K003793 · C.R. Bard, Inc. · Jan 2001
GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE
K003753 · Uresil Corp. · Jan 2001
S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS)
K003365 · Cordis Corp. · Nov 2000
NIR BILLIARY STENT SYSTEM
K002133 · Boston Scientific Corp · Oct 2000
DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM
K002143 · Guidant Corp. · Oct 2000