Clearance Summary
Medical Disposable Sterile Needle Electrode received FDA 510(k) clearance under submission number K232581, sponsored by Suzhou Haishen Medical Device Associates Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2023-12-04.
- Submission: K232581
- Applicant / Sponsor: Suzhou Haishen Medical Device Associates Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1350
- Decision date: 2023-12-04
Classification & Regulation
This clearance is catalogued under FDA product code GXZ and 21 CFR 882.1350, within the Neurology review panel as a Class II device.