Cleared Traditional

K153264 - EasyPass Guidewire (FDA 510(k) Clearance)

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

K153264 · Medi-Globe Corporation · Gastroenterology & Urology device
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May 2016
Decision
189d
Days
Class 2
Risk

K153264 is an FDA 510(k) clearance for the EasyPass Guidewire. Classified as Endoscopic Guidewire, Gastroenterology-urology (product code OCY), Class II - Special Controls.

Submitted by Medi-Globe Corporation (Tempe, US). The FDA issued a Cleared decision on May 19, 2016 after a review of 189 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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.

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Submission Details

510(k) Number K153264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2015
Decision Date May 19, 2016
Days to Decision 189 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
59d slower than avg
Panel avg: 130d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OCY Endoscopic Guidewire, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Provide Access To Gi Or Gu Tract For The Purpose Of Passing Or Exchanging Other Accessories.
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.