Clearance Summary
AtriCure cryoICE cryo-ablation probe (CRYO2) received FDA 510(k) clearance under submission number K180138, sponsored by AtriCure, 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 2018-02-15.
- Submission: K180138
- Applicant / Sponsor: AtriCure, Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4250
- Decision date: 2018-02-15
Classification & Regulation
This clearance is catalogued under FDA product code GXH and 21 CFR 882.4250, within the Neurology review panel as a Class II device.