510(k) K053363

DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES by Ad-Tech Medical Instrument Corp — Product Code GYC

K053363 is an FDA 510(k) premarket notification submitted by Ad-Tech Medical Instrument Corp for the device "DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES". The FDA issued a decision of Substantially Equivalent on May 30, 2006. The device falls under product code GYC (Electrode, Cortical), a Class II device regulated under 21 CFR 882.1310. Ad-Tech Medical Instrument Corp has at least 10 other 510(k) clearances on record.