Clearance Summary
SURGIVISION INC. CLEARPOINT SYSTEM received FDA 510(k) clearance under submission number K111073, sponsored by Surgi-Vision, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2011-06-22.
- Submission: K111073
- Applicant / Sponsor: Surgi-Vision, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2011-06-22
Classification & Regulation
This clearance is catalogued under FDA product code ORR and 21 CFR 882.4560, within the Neurology review panel as a Class II device.