Cleared Traditional

K220036 - Wellead Ureteral Catheter (FDA 510(k) Clearance)

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

K220036 · Well Lead Medical Co., Ltd. · Gastroenterology & Urology device
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Dec 2022
Decision
345d
Days
Class 2
Risk

K220036 is an FDA 510(k) clearance for the Wellead Ureteral Catheter. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Well Lead Medical Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on December 16, 2022 after a review of 345 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K220036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2022
Decision Date December 16, 2022
Days to Decision 345 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
215d slower than avg
Panel avg: 130d · This submission: 345d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOD Catheter, Urological
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.