| Device Type ID | 3687 |
| Device Name | Electrode, Depth |
| Regulation Description | Depth 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 | 882.1330 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GZL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 3687 |
| Device | Electrode, Depth |
| Product Code | GZL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Depth Electrode. |
| CFR Regulation Number | 882.1330 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AD-TECH | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
AD-TECH MEDICAL INSTRUMENT CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
ALPHA OMEGA ENGINEERING LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DIXI MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FHC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NATUS MEDICAL INCORPORATED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PMT CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 11 |
Material Separation | 2 |
Human Factors Issue | 1 |
Incorrect Device Or Component Shipped | 1 |
Fluid Leak | 1 |
Temperature Problem | 1 |
Use Of Device Problem | 1 |
Difficult To Remove | 1 |
| Total Device Problems | 19 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ad-Tech Medical Instrument Corporation | II | Oct-21-2014 |