Clearance Summary
Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint Ablation Generator HP (CAGENHP); Emprint Ablation Pump (CAPUMP1); Covidien Ablation Footswitch (RFASW); Emprint Reinforced Percutaneous Antenna 15cm (CA15L2); Emprint Reinforced Percutaneous Antenna 20cm (CA20L2); Emprint Reinforced Percutaneous Antenna 30cm (CA30L2); Covidien Remote Temperature Probe (RTP20); Covidien Remote Temperature Probe, Bulk (RTP20B) received FDA 510(k) clearance under submission number K233838, sponsored by Medtronic, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2024-03-28.
- Submission: K233838
- Applicant / Sponsor: Medtronic, Inc.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2024-03-28
Classification & Regulation
This clearance is catalogued under FDA product code NEY and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.