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FDA 510(k)

Leksell Stereotactic System, Injection/ Aspiration Needle Kit

K-Number: K152558 · 2016-03-02

ApplicantElekta Instrument AB
Decision Date2016-03-02
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Leksell Stereotactic System, Injection/ Aspiration Needle Kit is a medical device manufactured by Elekta Instrument AB. It received FDA 510(k) clearance on 2016-03-02 under approval number K152558. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Leksell Stereotactic System, Injection/ Aspiration Needle Kit?

Leksell Stereotactic System, Injection/ Aspiration Needle Kit is a medical device that received FDA 510(k) clearance on 2016-03-02. It is manufactured by Elekta Instrument AB. The 510(k) number is K152558.

When was Leksell Stereotactic System, Injection/ Aspiration Needle Kit approved by the FDA?

Leksell Stereotactic System, Injection/ Aspiration Needle Kit received FDA 510(k) clearance on 2016-03-02, under approval number K152558.

What company makes Leksell Stereotactic System, Injection/ Aspiration Needle Kit?

Leksell Stereotactic System, Injection/ Aspiration Needle Kit is manufactured by Elekta Instrument AB.

What is the FDA product code for Leksell Stereotactic System, Injection/ Aspiration Needle Kit?

The FDA product code for Leksell Stereotactic System, Injection/ Aspiration Needle Kit is HAW.

Related Clinical Trials

NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT07491952 Continuous Dual Aspiration Technique With Zoom System for Stroke RECRUITING NCT04910841 Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine RECRUITING NCT06747117 A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II) RECRUITING NCT07101809 Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology RECRUITING NCT04798261 Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System RECRUITING

Other Devices by Elekta Instrument AB

K160440Leksell Gamma Knife Icon K171123Leksell Vantage Stereotactic System K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon K173791Leksell GammaPlan K190887Leksell Vantage Stereotactic System

Related Devices (Code: HAW)

K162604Cranial Reducing TubesMedtronic Navigation, Inc. K160811CRW STEREOTACTIC SYSTEMIntegra LifeSciences Corporation K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. K152764EXACTECH GPSBlue Ortho K160523BrightMatter Guide with BrightMatter PointerSynaptive Medical, Inc. K151156Fiagon Navigation SystemFiagon GmbH

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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