Cleared Traditional

K043254 - PATHWAY URETERAL ACCESS SHEATH

K043254 is an FDA 510(k) clearance for PATHWAY URETERAL ACCESS SHEATH, manufactured by Onset Medical Corporation. The device is a Class 2 Gastroenterology & Urology device with product code EZN cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K043254 · Onset Medical Corporation · Gastroenterology & Urology device
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Feb 2005
Decision
78d
Days
Class 2
Risk

K043254 is an FDA 510(k) clearance for the PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH. Classified as Dilator, Catheter, Ureteral (product code EZN), Class II - Special Controls.

Submitted by Onset Medical Corporation (Mission Viejo, US). The FDA issued a Cleared decision on February 10, 2005 after a review of 78 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 Onset Medical Corporation devices

FDA 510(k) Submission Details - K043254

510(k) Number K043254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2004
Decision Date February 10, 2005
Days to Decision 78 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 130d · This submission: 78d
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 44
Devices cleared under the same product code (EZN) and FDA review panel - the closest regulatory comparables to K043254.
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
COOK URETERAL BALLOON DILATION CATHETER SET
K040127 · Cook Urological, Inc. · Apr 2004
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