Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes— 510(k) K163355
Substantially EquivalentAd-Tech Medical Instrument Corporation
FDA 510(k) clearance K163355 for Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes, Substantially Equivalent on 2017-04-12. Applicant: Ad-Tech Medical Instrument Corporation. Device class: 2.
Clearance details
- Applicant
- Ad-Tech Medical Instrument Corporation
- Product code
- Code GZL
- Device class
- Class 2
- Regulation
- 21 CFR 882.1330
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Racine, WI, US
Recent devices under product code GZL
view allMore clearances from Ad-Tech Medical Instrument Corporation
view all- K191186 — Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode
- K181544 — Anchor Bolt (as an accessory to Depth Electrodes)
- K170442 — Cranial Drill Bits and Accessories
- K152769 — FREMAP ELECTRODE
- K152547 — DNAP Electrode
Recalls naming K163355
K-number listed on FDA's recall record- Z-0219-2025 — AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode
- Z-0220-2025 — AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode
- Z-0221-2025 — AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
- Z-2407-2019 — Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes
- Z-2396-2019 — AD-TECH Spencer Probe Depth Electrode Product Usage: 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.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K163355.
Data sourced from openFDA. This site is unofficial and independent of the FDA.