Clearance Summary
DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES received FDA 510(k) clearance under submission number K053363, sponsored by Ad-Tech Medical Instrument Corp. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2006-05-30.
- Submission: K053363
- Applicant / Sponsor: Ad-Tech Medical Instrument Corp
- Clearance pathway: Abbreviated
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1310
- Decision date: 2006-05-30
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.