Rusch Latex Gold Foley Catheter

FDA 510(k) K262056 · Teleflex Medical Sdn. Bhd.

Substantially Equivalent

510(k) numberK262056

Submission

Device name
Rusch Latex Gold Foley Catheter
Applicant
Teleflex Medical Sdn. Bhd.
Kamunting, MY
Received
June 18, 2026
Decision date
August 5, 2026
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
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
K231101Flume CatheterEZL · Special Flume Catheter Company, Ltd.06/29/2023SE

More from Flume Catheter Company, Ltd.

510(k)DeviceDecision
K252643Iso-Gard Filter Straight; Humid-Vent Filter Compact AngledCAH · Traditional 05/15/2026SE
K252537Rusch SoftSimplastic Foley CathetersEZL · Traditional 01/20/2026SE

Questions and answers

When was Rusch Latex Gold Foley Catheter cleared by the FDA?

Rusch Latex Gold Foley Catheter (K262056) received a 510(k) decision of Substantially Equivalent on August 5, 2026, 48 days after the submission was received.

What is the product code of K262056?

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