Clearance Summary
BRAIN BIOPSY NEEDLE received FDA 510(k) clearance under submission number K112094, 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 2012-04-24.
- Submission: K112094
- Applicant / Sponsor: Ad-Tech Medical Instrument Corp
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2012-04-24
Classification & Regulation
This clearance is catalogued under FDA product code HAW and 21 CFR 882.4560, within the Neurology review panel as a Class II device.