Cleared Special

K003450 - INTRASTENT DOUBLESTRUT PARAMOUNT BILIAR...

K003450 is an FDA 510(k) clearance for INTRASTENT DOUBLESTRUT PARAMOUNT BILIAR..., 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 30-day FDA review.

K003450 · Intratherapeutics, Inc. · Gastroenterology & Urology device
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Dec 2000
Decision
30d
Days
Class 2
Risk

K003450 is an FDA 510(k) clearance for the INTRASTENT DOUBLESTRUT PARAMOUNT 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 December 7, 2000 after a review of 30 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 Intratherapeutics, Inc. devices

FDA 510(k) Submission Details - K003450

510(k) Number K003450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received November 07, 2000
Decision Date December 07, 2000
Days to Decision 30 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
100d faster than avg
Panel avg: 130d · This submission: 30d
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 K003450.
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
MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K003336 · Cordis Corp. · Nov 2000
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