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FDA 510(k)

Medical Disposable Sterile Needle Electrode

K-Number: K232581 · 2023-12-04

ApplicantSuzhou Haishen Medical Device Associates Co., Ltd.
Decision Date2023-12-04
Product CodeGXZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Medical Disposable Sterile Needle Electrode is a medical device manufactured by Suzhou Haishen Medical Device Associates Co., Ltd.. It received FDA 510(k) clearance on 2023-12-04 under approval number K232581. The device is classified under product code GXZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medical Disposable Sterile Needle Electrode?

Medical Disposable Sterile Needle Electrode is a medical device that received FDA 510(k) clearance on 2023-12-04. It is manufactured by Suzhou Haishen Medical Device Associates Co., Ltd.. The 510(k) number is K232581.

When was Medical Disposable Sterile Needle Electrode approved by the FDA?

Medical Disposable Sterile Needle Electrode received FDA 510(k) clearance on 2023-12-04, under approval number K232581.

What company makes Medical Disposable Sterile Needle Electrode?

Medical Disposable Sterile Needle Electrode is manufactured by Suzhou Haishen Medical Device Associates Co., Ltd..

What is the FDA product code for Medical Disposable Sterile Needle Electrode?

The FDA product code for Medical Disposable Sterile Needle Electrode is GXZ.

Related Clinical Trials

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Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025)

Other Devices by Suzhou Haishen Medical Device Associates Co., Ltd.

K232888Disposable Laryngeal Electrodes

Related Devices (Code: GXZ)

K161566DMS Disposable Subdermal Needle ElectrodesDaehan Medical Systems Co., Ltd. K192603Spes Medica Subdermal Needle ElectrodesSpes Medica Srl K190801PressOn Electrode HeadsetRhythmlink International, LLC K200984Guardian Needle ElectrodeRhythmlink International, LLC K231691Phantom XL Insulated DilatorsTeDan Surgical Innovations, Inc. K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe

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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