Cleared Traditional

K001648 - INTRASTENT DOUBLESTRUT PARAMOUNT

K001648 is an FDA 510(k) clearance for INTRASTENT DOUBLESTRUT PARAMOUNT, manufactured by Intratherapeutics, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K001648 · Intratherapeutics, Inc. · Gastroenterology & Urology device
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Aug 2000
Decision
90d
Days
Class 2
Risk

K001648 is an FDA 510(k) clearance for the INTRASTENT DOUBLESTRUT PARAMOUNT. 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 August 28, 2000 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Intratherapeutics, Inc. devices

FDA 510(k) Submission Details - K001648

510(k) Number K001648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2000
Decision Date August 28, 2000
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 130d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K001648.
NIR BILLIARY STENT SYSTEM
K002133 · Boston Scientific Corp · Oct 2000
DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM
K002143 · Guidant Corp. · Oct 2000
MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER
K001338 · Boston Scientific Corp · Aug 2000
ANGIODYNAMICS ABSCESSION BILIARY DRAINAGE CATHETER
K002101 · AngioDynamics, Inc. · Jul 2000
S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K001843 · Cordis Corp. · Jul 2000
BX TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM
K001258 · Cordis Corp. · Jun 2000