Cleared Traditional

K011080 - BRIDGE SE SELF-EXPANDING STENT DELIVERY...

K011080 is the FDA 510(k) clearance for BRIDGE SE SELF-EXPANDING STENT DELIVERY... by Medtronic Ave, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K011080 · Medtronic Ave, Inc. · Gastroenterology & Urology device
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Oct 2001
Decision
185d
Days
Class 2
Risk

K011080 is an FDA 510(k) clearance for the BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Medtronic Ave, Inc. (Santa Rosa, US). The FDA issued a Cleared decision on October 11, 2001 after a review of 185 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 Medtronic Ave, Inc. devices

Submission Details

510(k) Number K011080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received April 09, 2001
Decision Date October 11, 2001
Days to Decision 185 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
55d slower than avg
Panel avg: 130d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 306
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K011080.
FANELLI BILIARY STENT
K010601 · Cook, Inc. · Nov 2001
WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE
K012752 · Boston Scientific Corp · Nov 2001
MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX
K012822 · Boston Scientific Scimed, Inc. · Oct 2001
MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K012993 · Cordis Corp. · Oct 2001
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO .035 DELIVERY SYSTEM
K012590 · Cordis Corp. · Sep 2001
PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM
K010411 · Cordis Corp. · Aug 2001