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MRI's All Silicone Foley Catheter

by Mri Manufacturing and Research, Inc.

510(k) K944676

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK944676 Date5 Apr 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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, 26 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 MRI's All Silicone Foley Catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. It is a balloon retention type catheter made entirely of silicone material. The device is designed for temporary drainage of the urinary bladder.

This catheter is supplied as a single-use device and is not intended for reuse. It is available in various sizes as specified by the manufacturer. The device is classified under product code EZL and regulation number 876.5130, with FDA 510(k) clearance K944676 obtained on April 5, 1996.

Other devices from Mri Manufacturing and Research, Inc.

Questions

AI-generated answers, 26 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 MRI's All Silicone Foley Catheter used for?

    The MRI's All Silicone Foley Catheter is a flexible tubular device inserted through the urethra to pass fluids to or from the urinary tract. It is designed specifically for temporary drainage of the urinary bladder and functions as a balloon retention type catheter.

  • Is this catheter reusable or single-use?

    The MRI's All Silicone Foley Catheter is supplied as a single-use device and is not intended for reuse. This design ensures patient safety by preventing cross-contamination that could occur with repeated use.

  • What sizes are available for this catheter?

    The MRI's All Silicone Foley Catheter is available in various sizes as specified by the manufacturer. The specific size options would be determined based on clinical needs and patient requirements, with appropriate sizing selected by healthcare professionals.

  • What is the regulatory status of this device?

    The MRI's All Silicone Foley Catheter has FDA 510(k) clearance K944676 obtained on April 5, 1996. It is classified under product code EZL and regulation number 876.5130, with a decision description of 'Substantially Equivalent' under the gastroenterology and urology advisory committee.