Cleared Traditional

K023090 - OPTION-VF URINARY CATHETER, FV14218

K023090 is an FDA 510(k) clearance for OPTION-VF URINARY CATHETER, manufactured by Opticon Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code EZL cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K023090 · Opticon Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
183d
Days
Class 2
Risk

K023090 is an FDA 510(k) clearance for the OPTION-VF URINARY CATHETER, FV14218. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Opticon Medical, Inc. (Dublin, US). The FDA issued a Cleared decision on March 19, 2003 after a review of 183 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.

FDA 510(k) Submission Details - K023090

510(k) Number K023090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2002
Decision Date March 19, 2003
Days to Decision 183 days
Submission Type Traditional
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
52d slower than avg
Panel avg: 131d · This submission: 183d
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 127
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K023090.
DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER
K024010 · The Kendall Company Div. of Tyco Healthcare Group · Jun 2003
PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND
K030813 · Primary Care Solutions, Inc. · May 2003
VITALCARE FOLEY CATHETER
K021939 · Vitalcare, Inc. · Apr 2003
ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865
K021142 · Fortune Medical Instrument Corp. · Oct 2002
3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS
K022287 · 3t Medical Systems, LLC · Sep 2002
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
K023090 · OPTION-VF URINARY CATHETER, FV14218
Download PDF FDA Summary Opticon Medical, Inc.