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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 the device name listed in this FDA 510(k) record. The listed applicant is Silq Technologies Corporation. It received FDA 510(k) clearance on 2022-07-01 under 510(k) 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. The listed applicant is Silq Technologies Corporation. The 510(k) number is K221625.

When did 2-Way 100% Silicone ClearTract Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for 2-Way 100% Silicone ClearTract Catheter?

The FDA 510(k) record lists Silq Technologies Corporation as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05931887Evaluation of the Novel Silq ClearTract Catheter in Patients With Chronic Urinary RetentionCOMPLETED

Other records listing Silq Technologies Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2330132-Way 100% Silicone Cleartract CatheterK2221182-Way 100% Silicone Cleartract Catheter

Related Devices (Code: EZL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262056Rusch Latex Gold Foley CatheterTeleflex Medical Sdn. Bhd.K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd.K243011Silicone Urethral Catheter (Silicone Urethral Catheter)Guangdong Ecan Medical Co., Ltd.K241424InnoCare Specialty Foley CatheterInnocare Urologics, LLCK232469Rüsch Latex Gold Foley CatheterTeleflexmedical, Inc.K240057TraumaGuard Intra-abdominal Pressure Sensing SystemSentinel Medical Technologies, LLC

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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