Cleared Traditional

K041983 - OPTION-VM URINARY CATHETER/ADPATER

K041983 is an FDA 510(k) clearance for OPTION-VM URINARY CATHETER/ADPATER, manufactured by Opticon Medical. The device is a Class 2 Gastroenterology & Urology device with product code EZL cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K041983 · Opticon Medical · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
117d
Days
Class 2
Risk

K041983 is an FDA 510(k) clearance for the OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Opticon Medical (Dublin, US). The FDA issued a Cleared decision on November 17, 2004 after a review of 117 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 Opticon Medical devices

FDA 510(k) Submission Details - K041983

510(k) Number K041983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2004
Decision Date November 17, 2004
Days to Decision 117 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
13d faster than avg
Panel avg: 130d · This submission: 117d
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 K041983.
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