Clearance Summary
CereLink ICP Monitor received FDA 510(k) clearance under submission number K210993, sponsored by Integra Lifesciences Production Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2021-04-30.
- Submission: K210993
- Applicant / Sponsor: Integra Lifesciences Production Corporation
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1620
- Decision date: 2021-04-30
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.