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FDA 510(k)

EZstim*III Peripheral Nerve Stimulator/Nerve Locator

K-Number: K162048 · 2016-12-05

ApplicantHalyard Health - Irvine
Decision Date2016-12-05
Product CodeKOI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EZstim*III Peripheral Nerve Stimulator/Nerve Locator is a medical device manufactured by Halyard Health - Irvine. It received FDA 510(k) clearance on 2016-12-05 under approval number K162048. The device is classified under product code KOI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EZstim*III Peripheral Nerve Stimulator/Nerve Locator?

EZstim*III Peripheral Nerve Stimulator/Nerve Locator is a medical device that received FDA 510(k) clearance on 2016-12-05. It is manufactured by Halyard Health - Irvine. The 510(k) number is K162048.

When was EZstim*III Peripheral Nerve Stimulator/Nerve Locator approved by the FDA?

EZstim*III Peripheral Nerve Stimulator/Nerve Locator received FDA 510(k) clearance on 2016-12-05, under approval number K162048.

What company makes EZstim*III Peripheral Nerve Stimulator/Nerve Locator?

EZstim*III Peripheral Nerve Stimulator/Nerve Locator is manufactured by Halyard Health - Irvine.

What is the FDA product code for EZstim*III Peripheral Nerve Stimulator/Nerve Locator?

The FDA product code for EZstim*III Peripheral Nerve Stimulator/Nerve Locator is KOI.

Related Clinical Trials

NCT07613489 Photobiomodulation for Diabetic Peripheral Neuropathy ACTIVE_NOT_RECRUITING NCT04246281 The RESET Clinical Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Back Pain COMPLETED NCT05664854 Electrical Impedance Tomography & Selective Stimulation of Vagus Nerve RECRUITING NCT06121232 Exploring the Benefit of Neuromodulation in Treating Chemo-induced Peripheral Neuropathy Using Peripheral Neuropathy Markers (Meissner's Corpuscles and Epidermal Nerve Fiber Density) and Sensory Testing (Quantitative Sensory and Gait Testing): A Single Center Feasibility Study ACTIVE_NOT_RECRUITING NCT01581580 Deep Brain Stimulation Surgery for Movement Disorders RECRUITING NCT07539025 Cervical Spinal Cord Associative Plasticity RECRUITING

Related PubMed Literature

PMID: 41470022 Low-intensity pulsed ultrasound for peripheral nerve regeneration: mechanobiological mechanisms and translational potential. Journal of translational medicine (2025)

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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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