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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 a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-08-23 under approval 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. It is manufactured by Cook Incorporated. The 510(k) number is K173657.

When was Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter approved by the FDA?

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

What company makes Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter?

Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter is manufactured by Cook Incorporated.

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

NCT07214948 Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction NOT_YET_RECRUITING NCT07595666 Comparison of NeuroEXPLORER PET/CT Versus Standard-of-care PET/CT of the Head and Neck Region. ENROLLING_BY_INVITATION NCT07274527 Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure RECRUITING NCT02932319 Outpatient Foley Catheter for Induction of Labor in Nulliparous for Prolonged Pregnancy COMPLETED NCT05931887 Evaluation of the Novel Silq ClearTract Catheter in Patients With Chronic Urinary Retention COMPLETED NCT07444372 Start CPAP Therapy in Obstructive Sleep Apnea Patients After Atrial Fibrillation Ablation NOT_YET_RECRUITING

Other Devices by Cook Incorporated

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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.

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