Cleared Abbreviated

K013174 - PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL,

K013174 is an FDA 510(k) clearance for PROGES FOLYSIL SILICONE FOLEY CATHETER, manufactured by Porges S.A.. The device is a Class 2 Gastroenterology & Urology device with product code EZL cleared through the Abbreviated 510(k) pathway after a 102-day FDA review.

K013174 · Porges S.A. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
102d
Days
Class 2
Risk

K013174 is an FDA 510(k) clearance for the PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FE.... Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Porges S.A. (Sarlat, FR). The FDA issued a Cleared decision on January 4, 2002 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - the FDA gastroenterology and urology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Porges S.A. devices

FDA 510(k) Submission Details - K013174

510(k) Number K013174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2001
Decision Date January 04, 2002
Days to Decision 102 days
Submission Type Abbreviated
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
29d faster than avg
Panel avg: 131d · This submission: 102d
Pathway characteristics
Standards-based clearance path.

EZL Device Classification - Class 2, Special Controls

Product Code EZL Catheter, Retention Type, Balloon
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 - EZL Catheter, Retention Type, Balloon

All 117
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K013174.
3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS
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K002612 · C.R. Bard, Inc. · Sep 2002
ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY
K013276 · Sewoon Medical Co., Ltd. · Feb 2002
PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL
K013172 · Porges S.A. · Dec 2001
DRAINAGE CATHETER OR FOLEY CATHETER
K010006 · Applied Medical Resources Corp. · Jul 2001
MENTOR SELF-CATH PLUS
K003784 · Mentor Corp. · Mar 2001