Cleared Traditional

Medical Disposable Sterile Needle Electrode

K232581 · Suzhou Haishen Medical Device Associates Co., Ltd. · Neurology

Dec 2023

Decision

101d

Days

Class 2

Risk

About This 510(k) Submission

K232581 is an FDA 510(k) clearance for the Medical Disposable Sterile Needle Electrode, a Electrode, Needle (Class II — Special Controls, product code GXZ), submitted by Suzhou Haishen Medical Device Associates Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on December 4, 2023, 101 days after receiving the submission on August 25, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1350.

Submission Details

510(k) Number	K232581 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 25, 2023
Decision Date	December 04, 2023
Days to Decision	101 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF