Cleared Traditional

K040127 - COOK URETERAL BALLOON DILATION CATHETER...

K040127 is the FDA 510(k) clearance for COOK URETERAL BALLOON DILATION CATHETER... by Cook Urological, Inc.. It is a Class 2 Gastroenterology & Urology device (product code EZN) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K040127 · Cook Urological, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
76d
Days
Class 2
Risk

K040127 is an FDA 510(k) clearance for the COOK URETERAL BALLOON DILATION CATHETER SET. Classified as Dilator, Catheter, Ureteral (product code EZN), Class II - Special Controls.

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on April 6, 2004 after a review of 76 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cook Urological, Inc. devices

Submission Details

510(k) Number K040127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received January 21, 2004
Decision Date April 06, 2004
Days to Decision 76 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
54d faster than avg
Panel avg: 130d · This submission: 76d
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 42
Devices cleared under the same product code (EZN) and FDA review panel - the closest regulatory comparables to K040127.
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
BARD UROFORCE BALLOON DILATION CATHETER
K993840 · C.R. Bard, Inc. · Jan 2000
BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND BALLOON DILATION CATHETERS, BALLOON DILATION C
K990072 · Cook Urological, Inc. · Mar 1999
UROLOGICAL BALLOON DILATATION CATHETER
K980795 · Boston Scientific Corp · Apr 1998