Cleared Traditional

K180354 - UroGen Ureteral Catheter (FDA 510(k) Clearance)

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

K180354 · Urogen Pharma, Ltd. · Gastroenterology & Urology device
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Oct 2018
Decision
264d
Days
Class 2
Risk

K180354 is an FDA 510(k) clearance for the UroGen Ureteral Catheter. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Urogen Pharma, Ltd. (Ra’Anana, IL). The FDA issued a Cleared decision on October 30, 2018 after a review of 264 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 Urogen Pharma, Ltd. devices

Submission Details

510(k) Number K180354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2018
Decision Date October 30, 2018
Days to Decision 264 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
134d slower than avg
Panel avg: 130d · This submission: 264d
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.

Regulatory Peers - KOD Catheter, Urological

All 237
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K180354.
Rubber Utility Catheter
K251864 · C.R. Bard, Inc. · Feb 2026
Wellead Ureteral Catheter
K220036 · Well Lead Medical Co., Ltd. · Dec 2022
allFlex Ureteral Catheters, Krait Ureteral Catheters
K220730 · Allwin Medical Devices, Inc. · Oct 2022
Urinary Catheter 12 Fr, Urinary Catheter 16 Fr
K211032 · Urogen Pharma, Ltd. · Nov 2021