Cleared Traditional

2-Way 100% Silicone Cleartract Catheter (K233013) - FDA 510(k) Clearance

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

K233013 · Silq Technologies Corporation · Gastroenterology & Urology device
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Jan 2024
Decision
123d
Days
Class 2
Risk

K233013 is an FDA 510(k) clearance for the 2-Way 100% Silicone Cleartract Catheter. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Silq Technologies Corporation (Sunny Isles Beach, US). The FDA issued a Cleared decision on January 23, 2024 after a review of 123 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 Silq Technologies Corporation devices

Submission Details

510(k) Number K233013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2023
Decision Date January 23, 2024
Days to Decision 123 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
7d faster than avg
Panel avg: 130d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 42
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K233013.
Rüsch Latex Gold Foley Catheter
K232469 · Teleflexmedical, Inc. · Aug 2024
TraumaGuard Intra-abdominal Pressure Sensing System
K240057 · Sentinel Medical Technologies, LLC · Apr 2024
Folysil Silicone Catheter
K233411 · Coloplast Corp. · Apr 2024
Teleflex Rusch SoftSimplastic Foley Catheters
K212077 · Teleflexmedical, Inc. · Jul 2023
Flume Catheter
K231101 · Flume Catheter Company, Ltd. · Jun 2023
Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F
K221020 · Potrero Medical, Inc. · Jan 2023