# K163355: Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes - Pathway: 510(k) (Traditional) - Applicant: Ad-Tech Medical Instrument Corporation - Decided: Apr 12, 2017 after 133 days - Product code: GZL (Electrode, Depth) - Device class: 2 - Regulation: 21 CFR 882.1330 - Recalls of this device: 5 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 6 generations back to K811452 (1981). 16 ancestors in all. 5 later devices descend from it; 4 cite it directly. 0 of 22 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K053358: Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth Electrodes, Ad-Tech Medical Instrument Corp (2006) Summary page 4. - K964644: AD-Tech's Depth Electrode, Ad-Tech Medical Instrument Corp (1997) Summary page 4. - K990788: AD-Tech's Foramen Ovale Electrode, Ad-Tech Medical Instrument Corp (1999) Summary page 4. - K041604: Macro-Micro Depth Electrode, Ad-Tech Medical Instrument Corp (2004) Summary page 4. - K802151: PMT Depthalon Depth Corticography Elec, Progress Mankind Technology (1980) Summary page 4. - K151790: PMT Platinum Depthalon Depth Electrode, Pmt Corporation (2016) Summary page 4. ## Most influential descendants - K201678: iCE-SG Subcutaneous Electrode Arrays (2021), 1 descendant of its own - K250363: Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); Dept (2025), 0 descendants of its own - K223269: Spencer Probe Depth Electrodes (2023), 0 descendants of its own - K222706: iCE-SG2 Subcutaneous Electrode Kit (2022), 0 descendants of its own - K202087: DIXI Medical Microdeep Micro-Macro Depth Electrodes (2021), 0 descendants of its own ## Recalls of this device - Sep 19, 2024 · Class II · Z-0221-2025: Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly placed instead of the - Sep 19, 2024 · Class II · Z-0219-2025: Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly placed instead of the - Sep 19, 2024 · Class II · Z-0220-2025: Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly placed instead of the - Jun 18, 2019 · Class II · Z-2407-2019: Supplemental information provided with devices indicates that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved fo - Apr 16, 2019 · Class II · Z-2396-2019: An Ad-Tech Clinical Specialist, attended a case on April 15, 2019. During the case the surgeon encountered an issue after implanting four Ad-Tech depth electrodes. Upon initial device testing subseque ## Indications for use The Ad-Tech Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes) are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping. Source page: https://510kreport.com/device/K163355 Methodology: https://510kreport.com/methodology