Clearance Summary
LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE received FDA 510(k) clearance under submission number K020558, sponsored by Integra Neurosciences. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2002-03-21.
- Submission: K020558
- Applicant / Sponsor: Integra Neurosciences
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1620
- Decision date: 2002-03-21
Classification & Regulation
This clearance is catalogued under FDA product code GWM and 21 CFR 882.1620, within the Neurology review panel as a Class II device.