Clearance Summary
NEURO CHECK DEVICE WITH IO-FLEX WIRE received FDA 510(k) clearance under submission number K113533, sponsored by Baxano, 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 2012-04-11.
- Submission: K113533
- Applicant / Sponsor: Baxano, Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4840
- Decision date: 2012-04-11
Classification & Regulation
This clearance is catalogued under FDA product code HAE and 21 CFR 882.4840, within the Neurology review panel as a Class II device.