Cleared Abbreviated

K013172 - PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL

K013172 is an FDA 510(k) clearance for PORGES SILICONE PROSTATECTOMY 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 87-day FDA review.

K013172 · Porges S.A. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
87d
Days
Class 2
Risk

K013172 is an FDA 510(k) clearance for the PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE T.... Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Porges S.A. (Le Plessis Robinson Cedex, FR). The FDA issued a Cleared decision on December 20, 2001 after a review of 87 days - a notably fast clearance 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 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 - K013172

510(k) Number K013172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2001
Decision Date December 20, 2001
Days to Decision 87 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
44d faster than avg
Panel avg: 131d · This submission: 87d
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 K013172.
BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3CC BALLOON: 17008,170010,5CC BALLOON
K002612 · C.R. Bard, Inc. · Sep 2002
ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY
K013276 · Sewoon Medical Co., Ltd. · Feb 2002
PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL,
K013174 · Porges S.A. · Jan 2002
DRAINAGE CATHETER OR FOLEY CATHETER
K010006 · Applied Medical Resources Corp. · Jul 2001
MENTOR SELF-CATH PLUS
K003784 · Mentor Corp. · Mar 2001
BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED)
K003289 · C.R. Bard, Inc. · Jan 2001