510(k) K232581

Medical Disposable Sterile Needle Electrode by Suzhou Haishen Medical Device Associates Co., Ltd. — Product Code GXZ

K232581 is an FDA 510(k) premarket notification submitted by Suzhou Haishen Medical Device Associates Co., Ltd. for the device "Medical Disposable Sterile Needle Electrode". The FDA issued a decision of Substantially Equivalent on December 4, 2023. The device falls under product code GXZ (Electrode, Needle), a Class II device regulated under 21 CFR 882.1350. Suzhou Haishen Medical Device Associates Co., Ltd. has at least 1 other 510(k) clearance on record.