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 the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Haishen Medical Device Associates Co., Ltd.. It received FDA 510(k) clearance on 2023-12-04 under 510(k) 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. The listed applicant is Suzhou Haishen Medical Device Associates Co., Ltd.. The 510(k) number is K232581.

When did Medical Disposable Sterile Needle Electrode receive FDA 510(k) clearance?

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

Who is the listed applicant for Medical Disposable Sterile Needle Electrode?

The FDA 510(k) record lists Suzhou Haishen Medical Device Associates Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.