Clearance Summary
Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) received FDA 510(k) clearance under submission number K191346, sponsored by Blackrock Microsystems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2020-02-14.
- Submission: K191346
- Applicant / Sponsor: Blackrock Microsystems
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1310
- Decision date: 2020-02-14
Classification & Regulation
This clearance is catalogued under FDA product code GYC and 21 CFR 882.1310, within the Neurology review panel as a Class II device.