| Device Type ID | 3673 |
| Device Name | Electrode, Needle |
| Regulation Description | Needle 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 | 882.1350 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GXZ |
| 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 | 3673 |
| Device | Electrode, Needle |
| Product Code | GXZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Needle Electrode. |
| CFR Regulation Number | 882.1350 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DAEHAN MEDICAL SYSTEMS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEUROINVENT INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Material Separation | 7 |
Adverse Event Without Identified Device Or Use Problem | 5 |
Failure To Sense | 4 |
Lead(s), Burn(s) From | 3 |
Break | 3 |
Detachment Of Device Or Device Component | 2 |
Noise, Audible | 2 |
Device Operates Differently Than Expected | 2 |
Device Sensing Problem | 2 |
Material Integrity Problem | 1 |
Contamination During Use | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Low Impedance | 1 |
Use Of Device Problem | 1 |
Mechanical Problem | 1 |
Unable To Obtain Readings | 1 |
Component Or Accessory Incompatibility | 1 |
False Negative Result | 1 |
Unsealed Device Packaging | 1 |
Sensing Intermittently | 1 |
| Total Device Problems | 41 |