Clearance Summary
SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm received FDA 510(k) clearance under submission number K151536, sponsored by Mri Interventions, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2015-07-08.
- Submission: K151536
- Applicant / Sponsor: Mri Interventions, Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4300
- Decision date: 2015-07-08
Classification & Regulation
This clearance is catalogued under FDA product code HBG and 21 CFR 882.4300, within the Neurology review panel as a Class II device.