Clearance Summary
CRANIAL DRILL received FDA 510(k) clearance under submission number K000195, 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 2000-04-20.
- Submission: K000195
- Applicant / Sponsor: Image-Guided Neurologics, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4370
- Decision date: 2000-04-20
Classification & Regulation
This clearance is catalogued under FDA product code HBB and 21 CFR 882.4370, within the Neurology review panel as a Class II device.