Clearance Summary
EZ-STIK Electrodes received FDA 510(k) clearance under submission number K223775, sponsored by South Dakota Partners. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2023-01-03.
- Submission: K223775
- Applicant / Sponsor: South Dakota Partners
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1320
- Decision date: 2023-01-03
Classification & Regulation
This clearance is catalogued under FDA product code GXY and 21 CFR 882.1320, within the Neurology review panel as a Class II device.