Cleared Traditional

Balloon Catheter and Balloon Ureteral Dilator Set (K172588) - FDA 510(k) Clearance

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

K172588 · Cook Incorporated · Gastroenterology & Urology device
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Apr 2018
Decision
233d
Days
Class 2
Risk

K172588 is an FDA 510(k) clearance for the Balloon Catheter and Balloon Ureteral Dilator Set. Classified as Dilator, Catheter, Ureteral (product code EZN), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on April 19, 2018 after a review of 233 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5470 - 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 K172588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received August 29, 2017
Decision Date April 19, 2018
Days to Decision 233 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
103d slower than avg
Panel avg: 130d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZN Dilator, Catheter, Ureteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5470
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 - EZN Dilator, Catheter, Ureteral

All 25
Devices cleared under the same product code (EZN) and FDA review panel - the closest regulatory comparables to K172588.
Ureteral Dilator Sets, Ureteral Dilators
K173654 · Cook Incorporated · Jul 2018
Safety Wire Guide Introducer
K180756 · Cook Incorporated · May 2018
Cook 810 Set, Desilets-Hoffman Introducer Set
K180028 · Cook Incorporated · May 2018
UROMAX ULTRA BALLOON DILATATION CATHETER
K130804 · Boston Scientific Corporation · May 2013
U-BALLOON DILATION CATHETER
K050875 · C.R. Bard, Inc. · May 2005
COOK URETERAL BALLOON DILATION CATHETER SET
K040127 · Cook Urological, Inc. · Apr 2004