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Option-VF Urinary Catheter FV14218

by Opticon Medical, Inc.

510(k) K023090

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK023090 Date19 Mar 2003ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2830-2016 FDA Class II initiated 11 Jul 2016

    During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EZL
Device Class
Class II
Regulation
21 CFR Part 876.5130
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Option-VF Urinary Catheter FV14218 is a retention-type balloon catheter designed for urinary drainage. It falls under the category of a balloon catheter, intended for temporary or intermittent bladder drainage in clinical settings.

This device is supplied as a sterile, single-use, disposable product and is regulated under FDA 510(k) clearance (K023090) with a classification of Class II. It is intended for use in urological procedures, adhering to regulatory standards for medical devices in gastroenterology and urology. The catheter is packaged for one-time clinical application and must be discarded after use.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the intended use of the Option-VF Urinary Catheter?

    The Option-VF Urinary Catheter, model FV14218, is a retention-type balloon catheter intended for temporary or intermittent bladder drainage in clinical settings. It is designed for use in urological procedures.

  • Is the Option-VF Urinary Catheter intended for reuse?

    No, this device is supplied as a single-use, disposable product. It is packaged for one-time clinical application and must be discarded after use.

  • How is the Option-VF Urinary Catheter supplied to the clinician?

    The device is supplied as a sterile product, ensuring it is ready for immediate clinical use upon opening the packaging, provided the sterile barrier remains intact.

  • What is the regulatory classification of this device?

    The Option-VF Urinary Catheter is regulated as a Class II medical device under FDA 510(k) clearance, specifically identified by K-number K023090.