Cleared Traditional

K133615 - WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER

K133615 is an FDA 510(k) clearance for WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER, manufactured by Well Lead Medical Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code EZD cleared through the Traditional 510(k) pathway after a 91-day FDA review.

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

FDA 510(k) Submission Details - K133615

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.

EZD Device Classification - Class 2, Special Controls

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 50
Devices cleared under the same product code (EZD) and FDA review panel - the closest regulatory comparables to K133615.
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BARD RITECATH INTERMITTENT CATHETER
K133470 · C.R. Bard, Inc. · Apr 2014
LOFRIC PRIMO, LOFRIC HYDRO-KIT
K122078 · Astra Tech, Inc. · Oct 2012
COMFORTGLIDE INTERMITENT CATHETER
K112137 · C.R. Bard, Inc. · Aug 2011
MEDLINE PVC URETHRAL CATHETER
K100302 · Medline Industries, Inc. · Jul 2010