Cleared Special

K033830 - OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218 (FDA 510(k) Clearance)

Also includes:
OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K033830 · Opticon Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
30d
Days
Class 2
Risk

K033830 is an FDA 510(k) clearance for the OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Opticon Medical, Inc. (Washington, US). The FDA issued a Cleared decision on January 9, 2004 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Opticon Medical, Inc. devices

Submission Details

510(k) Number K033830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2003
Decision Date January 09, 2004
Days to Decision 30 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 130d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.

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