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FDA 510(k)

2-Way 100% Silicone Cleartract Catheter

K-Number: K222118 · 2022-12-01

ApplicantSilq Technologies, Corp.
Decision Date2022-12-01
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

2-Way 100% Silicone Cleartract Catheter is a medical device manufactured by Silq Technologies, Corp.. It received FDA 510(k) clearance on 2022-12-01 under approval number K222118. 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 2022-12-01. It is manufactured by Silq Technologies, Corp.. The 510(k) number is K222118.

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

2-Way 100% Silicone Cleartract Catheter received FDA 510(k) clearance on 2022-12-01, under approval number K222118.

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

2-Way 100% Silicone Cleartract Catheter is manufactured by Silq Technologies, Corp..

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

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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.

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