Clearance Summary
GT5 conductive & abrasive gel received FDA 510(k) clearance under submission number K212787, sponsored by Wuhan Greentek Pty , 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 2021-11-08.
- Submission: K212787
- Applicant / Sponsor: Wuhan Greentek Pty , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1275
- Decision date: 2021-11-08
Classification & Regulation
This clearance is catalogued under FDA product code GYB and 21 CFR 882.1275, within the Neurology review panel as a Class II device.