Clearance Summary
Nitinol Thermocouple (TCN) Electrode received FDA 510(k) clearance under submission number K183177, sponsored by Boston Scientific Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2019-03-08.
- Submission: K183177
- Applicant / Sponsor: Boston Scientific Corporation
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4725
- Decision date: 2019-03-08
Classification & Regulation
This clearance is catalogued under FDA product code GXI and 21 CFR 882.4725, within the Neurology review panel as a Class II device.