Mri's All Silicone Irrigation 3-WAY Foley Catheter

FDA 510(k) K982970 · Mri Manufacturing and Research, Inc.

Substantially Equivalent

510(k) numberK982970

Submission

Device name
Mri's All Silicone Irrigation 3-WAY Foley Catheter
Applicant
Mri Manufacturing and Research, Inc.
New Port Riche, FL, US
Received
August 25, 1998
Decision date
October 28, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EZL – Catheter, Retention Type, Balloon
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5130
Specialty
Gastroenterology, Urology

Other 510(k)s with product code EZL

510(k)DeviceApplicantDecision
K260756TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)EZL · Traditional Sentinel Medical Technologies,09/04/2026SE
K262056Rusch Latex Gold Foley CatheterEZL · Traditional Teleflex Medical Sdn. Bhd.08/05/2026SE
K252537Rusch SoftSimplastic Foley CathetersEZL · Traditional Teleflex Medical Sdn. Bhd.01/20/2026SE
K243011Silicone Urethral Catheter (Silicone Urethral Catheter)EZL · Traditional Guangdong Ecan Medical Co., Ltd.06/16/2025SE
K241424InnoCare Specialty Foley CatheterEZL · Traditional Innocare Urologics, LLC09/18/2024SE
K232469Rüsch Latex Gold Foley CatheterEZL · Traditional Teleflexmedical, Inc.08/01/2024SE
K240057TraumaGuard Intra-abdominal Pressure Sensing SystemEZL · Traditional Sentinel Medical Technologies, LLC04/17/2024SE
K233411Folysil Silicone CatheterEZL · Traditional Coloplast Corp.04/15/2024SE
K2330132-Way 100% Silicone Cleartract CatheterEZL · Traditional Silq Technologies Corporation01/23/2024SE
K212077Teleflex Rusch SoftSimplastic Foley CathetersEZL · Traditional Teleflexmedical, Inc.07/27/2023SE

More from Teleflexmedical, Inc.

510(k)DeviceDecision
K083685Endovive Low Profile Replacement Gastrostomy Tube, Model 82XX, 8283, 8284, 8285KNT · Traditional 06/25/2009SE
K944676Mri's All Silicone Foley CatheterEZL · Traditional 04/05/1996SE

Questions and answers

When was Mri's All Silicone Irrigation 3-WAY Foley Catheter cleared by the FDA?

Mri's All Silicone Irrigation 3-WAY Foley Catheter (K982970) received a 510(k) decision of Substantially Equivalent on October 28, 1998, 64 days after the submission was received.

What is the product code of K982970?

The FDA product code is EZL – Catheter, Retention Type, Balloon, a Class II (moderate risk) device regulated under 21 CFR 876.5130.