Cleared Traditional

URETERAL CATHETER (K923729) - FDA 510(k) Clearance

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

K923729 · Cook Urological, Inc. · Gastroenterology & Urology device
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Dec 1993
Decision
498d
Days
Class 2
Risk

K923729 is an FDA 510(k) clearance for the URETERAL CATHETER. Classified as Catheter, Ureteral, Gastro-urology (product code EYB), Class II - Special Controls.

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on December 7, 1993 after a review of 498 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Cook Urological, Inc. devices

Submission Details

510(k) Number K923729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1992
Decision Date December 07, 1993
Days to Decision 498 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
368d slower than avg
Panel avg: 130d · This submission: 498d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EYB Catheter, Ureteral, Gastro-urology
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 - EYB Catheter, Ureteral, Gastro-urology

All 27
Devices cleared under the same product code (EYB) and FDA review panel - the closest regulatory comparables to K923729.
RocaTub Ureteral Catheter
K192183 · Promepal Sam · Apr 2020
Dornier MINNOW Ureteral Catheter
K191187 · Dornier Medtech America, Inc. · Sep 2019
UPJ Occlusion Balloon Catheter
K183323 · Cook Incorporated · Aug 2019
Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter
K182695 · Cook Incorporated · Jun 2019
Ureteric Catheters
K182122 · Coloplast Corp. · Oct 2018
Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter
K180182 · Cook Incorporated · Sep 2018