Cleared Traditional

X-Suit NIR Biliary Metallic Stent (K150487) - FDA 510(k) Clearance

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

K150487 · Medinol, Ltd. · Gastroenterology & Urology device
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Feb 2016
Decision
352d
Days
Class 2
Risk

K150487 is an FDA 510(k) clearance for the 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. (Tel Aviv, IL). The FDA issued a Cleared decision on February 12, 2016 after a review of 352 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K150487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received February 25, 2015
Decision Date February 12, 2016
Days to Decision 352 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
222d slower than avg
Panel avg: 130d · This submission: 352d
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 K150487.
AngioDynamics Total Abscession Biliary Drainage Catheter
K170743 · AngioDynamics, Inc. · Mar 2017
Express SD Biliary Monorail Premounted Stent System
K162404 · Boston Scientific Corporation · Oct 2016
Soehendra Stent Retriever
K161203 · Wilson-Cook Medical, Inc. · May 2016
WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary
K152853 · Boston Scientific Corp · Nov 2015
Elation Wireguided Balloon Dilation Catheter
K151925 · Merit Medical Systems, Inc. · Nov 2015
Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set
K152524 · Cook Incorporated · Sep 2015