510(k) K211954
K211954 is an FDA 510(k) premarket notification submitted by Spes Medica Srl for the device "Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid". The FDA issued a decision of Substantially Equivalent on November 10, 2022. The device falls under product code GYC (Electrode, Cortical), a Class II device regulated under 21 CFR 882.1310. Spes Medica Srl has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 10, 2022
- Date Received
- June 23, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Cortical
- Device Class
- Class II
- Regulation Number
- 882.1310
- Review Panel
- NE
- Submission Type