Clearance Summary
NAVIGUS NEXDRIVE, MODEL MI-3000 received FDA 510(k) clearance under submission number K043091, 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 2005-02-07.
- Submission: K043091
- Applicant / Sponsor: Image-Guided Neurologics, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2005-02-07
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.