Cleared Traditional

K031360 - GI SUPPLY BILIARY STENT

K031360 is an FDA 510(k) clearance for GI SUPPLY BILIARY STENT, manufactured by Gi Supply. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K031360 · Gi Supply · Gastroenterology & Urology device
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Sep 2003
Decision
147d
Days
Class 2
Risk

K031360 is an FDA 510(k) clearance for the GI SUPPLY BILIARY STENT. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Gi Supply (Willington, US). The FDA issued a Cleared decision on September 24, 2003 after a review of 147 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 Gi Supply devices

FDA 510(k) Submission Details - K031360

510(k) Number K031360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2003
Decision Date September 24, 2003
Days to Decision 147 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 130d · This submission: 147d
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 K031360.
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
PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K032137 · Cordis 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