510(k) K183177

Nitinol Thermocouple (TCN) Electrode by Boston Scientific Corporation — Product Code GXI

K183177 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "Nitinol Thermocouple (TCN) Electrode". The FDA issued a decision of Substantially Equivalent on March 8, 2019. The device falls under product code GXI (Probe, Radiofrequency Lesion), a Class II device regulated under 21 CFR 882.4725. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.