| Device Type ID | 3676 |
| Device Name | Electrode, Cortical |
| Regulation Description | Cortical Electrode. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.1310 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GYC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 3676 |
| Device | Electrode, Cortical |
| Product Code | GYC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cortical Electrode. |
| CFR Regulation Number | 882.1310 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MICROMED S.P.A. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Material Separation | 6 |
Device Operates Differently Than Expected | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Residue After Decontamination | 1 |
Energy Output To Patient Tissue Incorrect | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Improper Device Output | 1 |
Detachment Of Device Component | 1 |
Device Alarm System | 1 |
No Audible Prompt / Feedback | 1 |
Display Or Visual Feedback Problem | 1 |
No Device Output | 1 |
Defective Device | 1 |
Output Problem | 1 |
Packaging Problem | 1 |
Noise, Audible | 1 |
| Total Device Problems | 23 |