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)

About This 510(k) Submission

K233838 is an FDA 510(k) clearance for the 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), a System, Ablation, Microwave And Accessories (Class II — Special Controls, product code NEY), submitted by Medtronic, Inc. (Lafayette, US). The FDA issued a Cleared decision on March 28, 2024, 115 days after receiving the submission on December 4, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.