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FDA 510(k)

Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter

K-Number: K173657 · 2018-08-23

ApplicantCook Incorporated
Decision Date2018-08-23
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2018-08-23 under 510(k) number K173657. 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 Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter?

Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter is a medical device that received FDA 510(k) clearance on 2018-08-23. The listed applicant is Cook Incorporated. The 510(k) number is K173657.

When did Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter receive FDA 510(k) clearance?

Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter received FDA 510(k) clearance on 2018-08-23, under 510(k) number K173657.

Who is the listed applicant for Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter?

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

What is the FDA product code for Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter?

The FDA product code for Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter is EZL.

Related Clinical Trials

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NCT05931887Evaluation of the Novel Silq ClearTract Catheter in Patients With Chronic Urinary RetentionCOMPLETEDNCT07782762Effectiveness of the NowCath Foley in Reducing Catheter-Associated UTIs and Blockages in Long-Term Indwelling Catheter Users (REDUCE)RECRUITING

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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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