Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes
FDA 510(k) clearance K163355 · decided 2017-04-12
Clearance details
- K-number
- K163355
- Device name
- Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes
- Applicant
- Ad-Tech Medical Instrument Corporation
- Decision
- Substantially Equivalent
- Date received
- 2016-11-30
- Decision date
- 2017-04-12
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- GZL
- Device class
- 2
- Regulation number
- 882.1330
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Racine, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Dept recall (Z-0219-2025) | Ad-Tech Medical Instrument Corporation | 2024-10-24 |
| AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Dept recall (Z-0220-2025) | Ad-Tech Medical Instrument Corporation | 2024-10-24 |
| AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Dept recall (Z-0221-2025) | Ad-Tech Medical Instrument Corporation | 2024-10-24 |