Clearance Summary
DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES received FDA 510(k) clearance under submission number K053358, 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 2006-05-25.
- Submission: K053358
- Applicant / Sponsor: Ad-Tech Medical Instrument Corp
- Clearance pathway: Abbreviated
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1330
- Decision date: 2006-05-25
Classification & Regulation
This clearance is catalogued under FDA product code GZL and 21 CFR 882.1330, within the Neurology review panel as a Class II device.