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FDA 510(k)

Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle

K-Number: K183035 · 2019-05-17

ApplicantCook Incorporated
Decision Date2019-05-17
Product CodeLJE
DecisionUnknown

Device Summary

Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2019-05-17 under approval number K183035. The device is classified under product code LJE. FDA Decision: Unknown.

Frequently Asked Questions

What is the Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle?

Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle is a medical device that received FDA 510(k) clearance on 2019-05-17. It is manufactured by Cook Incorporated. The 510(k) number is K183035.

When was Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle approved by the FDA?

Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle received FDA 510(k) clearance on 2019-05-17, under approval number K183035.

What company makes Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle?

Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle is manufactured by Cook Incorporated.

What is the FDA product code for Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle?

The FDA product code for Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle is LJE.

Related Clinical Trials

NCT07540806 Ultrasound-Guided Percutaneous Needle Tenotomy (PNT) vs Percutaneous Ultrasonic Needle Tenotomy (PUT) for Gluteal Tendinosis NOT_YET_RECRUITING NCT06576128 Ultrasound-Guided Transversus Abdominis Plan (TAP) Block in Endovascular Cardiac Interventions RECRUITING NCT04766684 Clubfoot Tenotomy Trial COMPLETED NCT07247825 Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy. RECRUITING NCT05301959 Efficacy of Percutaneous Electrolysis in the Treatment of Achilles Tendinopathy RECRUITING NCT07273877 "Real-world Assessment of BP Control in Patients With Hypertension by the Netrod RDN System" - REACH-RDN ENROLLING_BY_INVITATION

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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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