Cleared Traditional

K061766 - EXPRESSWAY INTERMITTENT CATHETER

K061766 is an FDA 510(k) clearance for EXPRESSWAY INTERMITTENT CATHETER, manufactured by Percutaneous Systems, Incorporated. The device is a Class 2 Gastroenterology & Urology device with product code EZD cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K061766 · Percutaneous Systems, Incorporated · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
260d
Days
Class 2
Risk

K061766 is an FDA 510(k) clearance for the EXPRESSWAY INTERMITTENT CATHETER. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Percutaneous Systems, Incorporated (Mountain View, US). The FDA issued a Cleared decision on March 9, 2007 after a review of 260 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Percutaneous Systems, Incorporated devices

FDA 510(k) Submission Details - K061766

510(k) Number K061766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2006
Decision Date March 09, 2007
Days to Decision 260 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 130d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EZD Device Classification - Class 2, Special Controls

Product Code EZD Catheter, Straight
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - EZD Catheter, Straight

All 50
Devices cleared under the same product code (EZD) and FDA review panel - the closest regulatory comparables to K061766.
MEDLINE PVC URETHRAL CATHETER
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MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER
K050008 · Mentor Corp. · Jun 2005
KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER
K973546 · Kendall Healthcare Products Co. Div.Of Tyco Health · Nov 1997
CONVEEN EASICATH SET
K973070 · Coloplast Corp. · Nov 1997