510(k) K163355 ยท GZL Electrode, Depth
Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes
| Applicant | Ad-Tech Medical Instrument Corporation, Racine WI, US |
| Decision | Substantially Equivalent, Apr 12, 2017 |
| Received | Nov 30, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163355
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2024 | Ad-Tech Medical Instrument Corporation AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode Completed |
GZL | None listed |
| Oct 24, 2024 | Ad-Tech Medical Instrument Corporation AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode Completed |
GZL | None listed |
| Oct 24, 2024 | Ad-Tech Medical Instrument Corporation AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode Completed |
GZL | None listed |
| Jun 18, 2019 | Ad-Tech Medical Instrument Corporation Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes Terminated |
GZL | None listed |
| Apr 16, 2019 | Ad-Tech Medical Instrument Corporation 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, Wyle Terminated |
GZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.