510(k) K193232

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

K193232 is an FDA 510(k) premarket notification submitted by Covidien, LLC for the device "Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology". The FDA issued a decision of Substantially Equivalent on Feb 13, 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.