510(k) K203303

Emprint SX Ablation Platform with Thermosphere Technology by Covidien, LLC — Product Code NEY

K203303 is an FDA 510(k) premarket notification submitted by Covidien, LLC for the device "Emprint SX Ablation Platform with Thermosphere Technology". The FDA issued a decision of Substantially Equivalent on Dec 17, 2020. The device falls under product code NEY (System, Ablation, Microwave And Accessories), a Class II device regulated under 21 CFR 878.4400. Covidien, LLC has 224 other 510(k) clearances on record.