Clearance Summary
AD-TECH SUBDURAL ELECTRODE received FDA 510(k) clearance under submission number K970587, sponsored by Ad-Tech Medical Instrument Corp. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1997-05-09.
- Submission: K970587
- Applicant / Sponsor: Ad-Tech Medical Instrument Corp
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1310
- Decision date: 1997-05-09
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.