Clearance Summary
NAVIGUS II TRAJECTORY GUIDE received FDA 510(k) clearance under submission number K012366, sponsored by Image-Guided Neurologics, 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 2001-10-01.
- Submission: K012366
- Applicant / Sponsor: Image-Guided Neurologics, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2001-10-01
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.