Clearance Summary
Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode received FDA 510(k) clearance under submission number K191186, sponsored by Ad-Tech Medical Instrument Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2020-01-25.
- Submission: K191186
- Applicant / Sponsor: Ad-Tech Medical Instrument Corporation
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1310
- Decision date: 2020-01-25
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.