Cleared Traditional

K172588 - Balloon Catheter and Balloon Ureteral D...

K172588 is an FDA 510(k) clearance for Balloon Catheter and Balloon Ureteral D..., manufactured by Cook Incorporated. The device is a Class 2 Gastroenterology & Urology device with product code EZN cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K172588 · Cook Incorporated · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K172588

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.

EZN Device Classification - Class 2, Special Controls

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 46
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
Ureteral Dilators and Percutaneous Nephrostomy Dilators
K170531 · Coloplast Corp. · Aug 2017
UROMAX ULTRA BALLOON DILATATION CATHETER
K130804 · Boston Scientific Corporation · May 2013
U-BALLOON DILATION CATHETER
K050875 · C.R. Bard, Inc. · May 2005