Cleared Traditional

WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER (K133615) - FDA 510(k) Clearance

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

K133615 · Well Lead Medical Co., Ltd. · Gastroenterology & Urology device
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Feb 2014
Decision
91d
Days
Class 2
Risk

K133615 is an FDA 510(k) clearance for the WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Well Lead Medical Co., Ltd. (Apollo Beach, US). The FDA issued a Cleared decision on February 24, 2014 after a review of 91 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 Well Lead Medical Co., Ltd. devices

Submission Details

510(k) Number K133615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2013
Decision Date February 24, 2014
Days to Decision 91 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
39d faster than avg
Panel avg: 130d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZD Catheter, Straight
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 - EZD Catheter, Straight

All 43
Devices cleared under the same product code (EZD) and FDA review panel - the closest regulatory comparables to K133615.
Magic3 Go Intermittent Urinary Catheter
K150345 · C.R. Bard, Inc. · May 2015
Bard RiteCath Intermittent Urinary Catheter
K142575 · C.R. Bard, Inc. · Oct 2014
BARD RITECATH INTERMITTENT CATHETER
K133470 · C.R. Bard, Inc. · Apr 2014
COMFORTGLIDE INTERMITENT CATHETER
K112137 · C.R. Bard, Inc. · Aug 2011
MEDLINE PVC URETHRAL CATHETER
K100302 · Medline Industries, Inc. · Jul 2010