2-Way 100% Silicone Cleartract Catheter

FDA 510(k) K233013 · Silq Technologies Corporation

Substantially Equivalent

510(k) numberK233013

Submission

Device name
2-Way 100% Silicone Cleartract Catheter
Applicant
Silq Technologies Corporation
Sunny Isles Beach, FL, US
Received
September 22, 2023
Decision date
January 23, 2024
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
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
K2221182-Way 100% Silicone Cleartract CatheterEZL · Traditional 12/01/2022SE
K2216252-Way 100% Silicone ClearTract CatheterEZL · Special 07/01/2022SE

Questions and answers

When was 2-Way 100% Silicone Cleartract Catheter cleared by the FDA?

2-Way 100% Silicone Cleartract Catheter (K233013) received a 510(k) decision of Substantially Equivalent on January 23, 2024, 123 days after the submission was received.

What is the product code of K233013?

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