Cleared Traditional

K980290 - ITI STENT

K980290 is an FDA 510(k) clearance for ITI STENT, 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 176-day FDA review.

K980290 · Intratherapeutics, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
176d
Days
Class 2
Risk

K980290 is an FDA 510(k) clearance for the ITI STENT. 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 July 21, 1998 after a review of 176 days - an extended review cycle.

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 - K980290

510(k) Number K980290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1998
Decision Date July 21, 1998
Days to Decision 176 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
46d slower than avg
Panel avg: 130d · This submission: 176d
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 K980290.
CORDIS NITINOL STENT AND DELIVERY SYSTEM
K980823 · Cordis Corp. · Dec 1998
FLEXIMA
K982508 · Boston Scientific Corp · Oct 1998
WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS
K982005 · Boston Scientific Scimed, Inc. · Sep 1998
PERFLEX STAINLESS STEEL STENT AND DELIVERY SYSTEM
K980653 · Cordis Corp. · Jun 1998
MANAN VS ACCESS NEEDLE/SET
K980372 · Medical Device Technologies, Inc. · Apr 1998
MANAN BILIARY DRAINAGE CATHETER
K980191 · Medical Device Technologies, Inc. · Feb 1998