Cleared Traditional

PERCUCATH URINARY CATHETER (K090262) - FDA 510(k) Clearance

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

K090262 · Percuvision, LLC · Gastroenterology & Urology device
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May 2009
Decision
114d
Days
Class 2
Risk

K090262 is an FDA 510(k) clearance for the PERCUCATH URINARY CATHETER. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Percuvision, LLC (Gahanna, US). The FDA issued a Cleared decision on May 28, 2009 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Percuvision, LLC devices

Submission Details

510(k) Number K090262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2009
Decision Date May 28, 2009
Days to Decision 114 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 130d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code EZL Catheter, Retention Type, Balloon
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - EZL Catheter, Retention Type, Balloon

All 127
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