Clearance Summary
BURR HOLE COVER, MODEL XX received FDA 510(k) clearance under submission number K001096, 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 2000-10-25.
- Submission: K001096
- Applicant / Sponsor: Image-Guided Neurologics, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5250
- Decision date: 2000-10-25
Classification & Regulation
This clearance is catalogued under FDA product code GXR and 21 CFR 882.5250, within the Neurology review panel as a Class II device.