510(k) K163355

Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes by Ad-Tech Medical Instrument Corporation — Product Code GZL

K163355 is an FDA 510(k) premarket notification submitted by Ad-Tech Medical Instrument Corporation for the device "Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes". The FDA issued a decision of Substantially Equivalent on April 12, 2017. The device falls under product code GZL (Electrode, Depth), a Class II device regulated under 21 CFR 882.1330. Ad-Tech Medical Instrument Corporation has at least 7 other 510(k) clearances on record.