Cleared Traditional

K243011 - Silicone Urethral Catheter (Silicone Urethral Catheter) (FDA 510(k) Clearance)

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

K243011 · Guangdong Ecan Medical Co., Ltd. · Gastroenterology & Urology device
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Jun 2025
Decision
263d
Days
Class 2
Risk

K243011 is an FDA 510(k) clearance for the Silicone Urethral Catheter (Silicone Urethral Catheter). Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Guangdong Ecan Medical Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on June 16, 2025 after a review of 263 days - an extended review cycle.

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 Guangdong Ecan Medical Co., Ltd. devices

Submission Details

510(k) Number K243011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2024
Decision Date June 16, 2025
Days to Decision 263 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 130d · This submission: 263d
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 127
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K243011.
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