Cleared Traditional

MEDINOL X-SUIT NIR BILIARY METALLIC STENT (K081956) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K081956 · Medinol, Ltd. · Gastroenterology & Urology device
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Jan 2009
Decision
184d
Days
Class 2
Risk

K081956 is an FDA 510(k) clearance for the MEDINOL X-SUIT NIR BILIARY METALLIC STENT. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Medinol, Ltd. (Northborough, US). The FDA issued a Cleared decision on January 9, 2009 after a review of 184 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 Medinol, Ltd. devices

Submission Details

510(k) Number K081956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received July 09, 2008
Decision Date January 09, 2009
Days to Decision 184 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
54d slower than avg
Panel avg: 130d · This submission: 184d
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 220
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K081956.
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SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB
K062798 · Cordis Corp. · Feb 2008