Cleared Traditional

K182695 - Pigtail Ureteral Catheter Set

K182695 is an FDA 510(k) clearance for Pigtail Ureteral Catheter Set, manufactured by Cook Incorporated. The device is a Class 2 Gastroenterology & Urology device with product code EYB cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K182695 · Cook Incorporated · Gastroenterology & Urology device
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Jun 2019
Decision
263d
Days
Class 2
Risk

K182695 is an FDA 510(k) clearance for the Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter. 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 June 17, 2019 after a review of 263 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

FDA 510(k) Submission Details - K182695

510(k) Number K182695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received September 27, 2018
Decision Date June 17, 2019
Days to Decision 263 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
133d slower than avg
Panel avg: 130d · This submission: 263d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EYB Device Classification - Class 2, Special Controls

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 21
Devices cleared under the same product code (EYB) and FDA review panel - the closest regulatory comparables to K182695.
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
Ureteric Catheters
K182122 · Coloplast Corp. · Oct 2018
Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter
K180182 · Cook Incorporated · Sep 2018
Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters
K171043 · Coloplast Corp. · Dec 2017