Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

2-Way 100% Silicone ClearTract Catheter

K-Number: K221625 · 2022-07-01

ApplicantSilq Technologies Corporation
Decision Date2022-07-01
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

2-Way 100% Silicone ClearTract Catheter is a medical device manufactured by Silq Technologies Corporation. It received FDA 510(k) clearance on 2022-07-01 under approval number K221625. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 2-Way 100% Silicone ClearTract Catheter?

2-Way 100% Silicone ClearTract Catheter is a medical device that received FDA 510(k) clearance on 2022-07-01. It is manufactured by Silq Technologies Corporation. The 510(k) number is K221625.

When was 2-Way 100% Silicone ClearTract Catheter approved by the FDA?

2-Way 100% Silicone ClearTract Catheter received FDA 510(k) clearance on 2022-07-01, under approval number K221625.

What company makes 2-Way 100% Silicone ClearTract Catheter?

2-Way 100% Silicone ClearTract Catheter is manufactured by Silq Technologies Corporation.

What is the FDA product code for 2-Way 100% Silicone ClearTract Catheter?

The FDA product code for 2-Way 100% Silicone ClearTract Catheter is EZL.

Related Clinical Trials

NCT05931887 Evaluation of the Novel Silq ClearTract Catheter in Patients With Chronic Urinary Retention COMPLETED NCT07019623 U-CaVIT Versus Standard of Care for Prevention of Atonic Postpartum Hemorrhage After Cesarean Section in High-risk Women. RECRUITING NCT07530328 Clinical Evaluation of Copesilcup COMPLETED

Other Devices by Silq Technologies Corporation

K2330132-Way 100% Silicone Cleartract Catheter

Related Devices (Code: EZL)

K153655Accuryn Monitoring SystemPotrero Medical, Inc. K161770Rusch Silicone Foley CatheterTeleflexmedical, Inc. K162989Rusch Simplastic Foley CathetersTeleflexmedical, Inc. K181616PSM 3-Way Silicone Foley CatheterPathway, LLC K180781Bard Vertus Foley CatheterC.R. Bard, Inc. K181814AMSure Pre-filled Syringe for Balloon Inflation with Sterile WaterAmsino International, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑