Cleared Special

K061009 - PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS

K061009 is an FDA 510(k) clearance for PATHWAY BALLOON EXPANDABLE URETERAL ACC..., manufactured by Onset Medical Corporation. The device is a Class 2 Gastroenterology & Urology device with product code EZN cleared through the Special 510(k) pathway after a 20-day FDA review.

K061009 · Onset Medical Corporation · Gastroenterology & Urology device
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May 2006
Decision
20d
Days
Class 2
Risk

K061009 is an FDA 510(k) clearance for the PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS. 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 May 2, 2006 after a review of 20 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Onset Medical Corporation devices

FDA 510(k) Submission Details - K061009

510(k) Number K061009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2006
Decision Date May 02, 2006
Days to Decision 20 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 131d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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 51
Devices cleared under the same product code (EZN) and FDA review panel - the closest regulatory comparables to K061009.
Ureteral Dilators and Percutaneous Nephrostomy Dilators
K170531 · Coloplast Corp. · Aug 2017
GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER
K132181 · Olympus Surgical Technologies America · Oct 2013
UROMAX ULTRA BALLOON DILATATION CATHETER
K130804 · Boston Scientific Corporation · May 2013
U-BALLOON DILATION CATHETER
K050875 · C.R. Bard, Inc. · May 2005
PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH
K043254 · Onset Medical Corporation · Feb 2005
COOK URETERAL BALLOON DILATION CATHETER SET
K040127 · Cook Urological, Inc. · Apr 2004