Clearance Summary
LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM received FDA 510(k) clearance under submission number K093494, sponsored by Pathfinder Therapeutics, 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 2010-03-30.
- Submission: K093494
- Applicant / Sponsor: Pathfinder Therapeutics, Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2010-03-30
Classification & Regulation
This clearance is catalogued under FDA product code OEW and 21 CFR 882.4560, within the Neurology review panel as a Class II device.