Cleared Traditional

K233094 - Wellead® Latex Foley Catheter (FDA 510(k) Clearance)

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

K233094 · Well Lead Medical (Hainan) Co., Ltd. · Gastroenterology & Urology device
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Jun 2024
Decision
254d
Days
Class 2
Risk

K233094 is an FDA 510(k) clearance for the Wellead® Latex Foley Catheter. Classified as Catheter, Urological (antimicrobial) And Accessories (product code MJC), Class II - Special Controls.

Submitted by Well Lead Medical (Hainan) Co., Ltd. (Haikou, CN). The FDA issued a Cleared decision on June 6, 2024 after a review of 254 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 Well Lead Medical (Hainan) Co., Ltd. devices

Submission Details

510(k) Number K233094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2023
Decision Date June 06, 2024
Days to Decision 254 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
124d slower than avg
Panel avg: 130d · This submission: 254d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MJC Catheter, Urological (antimicrobial) And Accessories
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.