510(k) K201931

Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) by Dixi Medical — Product Code GYC

K201931 is an FDA 510(k) premarket notification submitted by Dixi Medical for the device "Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)". The FDA issued a decision of Substantially Equivalent on October 2, 2021. The device falls under product code GYC (Electrode, Cortical), a Class II device regulated under 21 CFR 882.1310. Dixi Medical has at least 2 other 510(k) clearances on record.