Medical Disposable Sterile Needle Electrode

FDA 510(k) K232581 · Suzhou Haishen Medical Device Associates Co., Ltd.

Substantially Equivalent

510(k) numberK232581

Submission

Device name
Medical Disposable Sterile Needle Electrode
Applicant
Suzhou Haishen Medical Device Associates Co., Ltd.
Suzhou, CN
Received
August 25, 2023
Decision date
December 4, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GXZ – Electrode, Needle
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1350
Specialty
Neurology

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K142470E-Shield Multi-paried Subdermal Needle ElectrodesGXZ · Special Neuroinvent, Inc.11/05/2014SE
K140200E-Shield Multi-Paired Subdermal Needle ElectrodesGXZ · Traditional Neuroinvent, Inc.07/18/2014SE
K130220MR Conditional Presson ElectrodeGXZ · Traditional Rhythmlink International, LLC07/22/2013SE
K130136Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal…GXZ · Traditional Technomed Europe07/19/2013SE

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Questions and answers

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

Medical Disposable Sterile Needle Electrode (K232581) received a 510(k) decision of Substantially Equivalent on December 4, 2023, 101 days after the submission was received.

What is the product code of K232581?

The FDA product code is GXZ – Electrode, Needle, a Class II (moderate risk) device regulated under 21 CFR 882.1350.