Cleared Traditional

K081184 - GORE VIABIL BILILARY ENDOPROSTHESIS

K081184 is an FDA 510(k) clearance for GORE VIABIL BILILARY ENDOPROSTHESIS, manufactured by W.L. Gore & Associates, Inc. Medical Products Div.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K081184 · W.L. Gore & Associates, Inc. Medical Products Div. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jul 2008
Decision
88d
Days
Class 2
Risk

K081184 is an FDA 510(k) clearance for the GORE VIABIL BILILARY ENDOPROSTHESIS. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. Medical Products Div. (Flagstaff, US). The FDA issued a Cleared decision on July 22, 2008 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all W.L. Gore & Associates, Inc. Medical Products Div. devices

FDA 510(k) Submission Details - K081184

510(k) Number K081184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received April 25, 2008
Decision Date July 22, 2008
Days to Decision 88 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 131d · This submission: 88d
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 409
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K081184.
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K072301 · Ev3, Inc. · Mar 2008