Cleared Traditional

Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter (K180182) - FDA 510(k) Clearance

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

K180182 · Cook Incorporated · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2018
Decision
234d
Days
Class 2
Risk

K180182 is an FDA 510(k) clearance for the Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Cat.... Classified as Catheter, Ureteral, Gastro-urology (product code EYB), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on September 14, 2018 after a review of 234 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 Cook Incorporated devices

Submission Details

510(k) Number K180182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2018
Decision Date September 14, 2018
Days to Decision 234 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
104d slower than avg
Panel avg: 130d · This submission: 234d
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 12
Devices cleared under the same product code (EYB) and FDA review panel - the closest regulatory comparables to K180182.
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
OCCLUDER OCCLUSION BALLOON CATHETER
K133750 · Boston Scientific Corporation · Jan 2014
MEDLINE RED RUBBER URETHRAL CATHETER
K092250 · Medline Industries, Inc. · Jan 2010
BARD DUAL LUMEN URETERAL CATHETER
K032521 · C.R. Bard, Inc. · Nov 2003