Cleared Traditional

K013276 - ALL-SILICONE FOLEY BALLOON CATHETER (TW...

Also marketed or referenced as:
THREE WAY, RADIOPAQUE)

K013276 is an FDA 510(k) clearance for ALL-SILICONE FOLEY BALLOON CATHETER (TW..., manufactured by Sewoon Medical Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code EZL cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K013276 · Sewoon Medical Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
137d
Days
Class 2
Risk

K013276 is an FDA 510(k) clearance for the ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Sewoon Medical Co., Ltd. (Deer Field, US). The FDA issued a Cleared decision on February 15, 2002 after a review of 137 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 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 Sewoon Medical Co., Ltd. devices

FDA 510(k) Submission Details - K013276

510(k) Number K013276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2001
Decision Date February 15, 2002
Days to Decision 137 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
7d slower than avg
Panel avg: 130d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 64
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K013276.
BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS
K040504 · C.R. Bard, Inc. · May 2004
AMSURE FOLEY CATHETER
K030120 · Amsino International, Inc. · Oct 2003
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
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