Clearance Summary
Fiagon Navigation PointerTube Straight and PointerTube Keat received FDA 510(k) clearance under submission number K163416, sponsored by Fiagon GmbH. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2017-02-16.
- Submission: K163416
- Applicant / Sponsor: Fiagon GmbH
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2017-02-16
Classification & Regulation
This clearance is catalogued under FDA product code PGW and 21 CFR 882.4560, within the Neurology review panel as a Class II device.