Cleared Traditional

Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter (K143609) - FDA 510(k) Clearance

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

K143609 · Olympus Surgical Technologies America · Gastroenterology & Urology device
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Mar 2015
Decision
98d
Days
Class 2
Risk

K143609 is an FDA 510(k) clearance for the Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Olympus Surgical Technologies America (Southborough, US). The FDA issued a Cleared decision on March 27, 2015 after a review of 98 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 Olympus Surgical Technologies America devices

Submission Details

510(k) Number K143609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2014
Decision Date March 27, 2015
Days to Decision 98 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
32d faster than avg
Panel avg: 130d · This submission: 98d
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 213
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K143609.
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K152524 · Cook Incorporated · Sep 2015
RESOLVE BILIARY LOCKING DRAINAGE CATHETER
K141408 · Merit Medical Systems, Inc. · Nov 2014
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K141335 · Boston Scientific Corp · Oct 2014
MUSTANG BALLOON DIALATION CATHETER
K141597 · Boston Scientific Corporation · Aug 2014