| Device Type ID | 3694 |
| Device Name | Instrument, Microsurgical |
| Regulation Description | Microsurgical Instrument. |
| 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) Exempt |
| CFR Regulation Number | 882.4525 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GZX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3694 |
| Device | Instrument, Microsurgical |
| Product Code | GZX |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Microsurgical Instrument. |
| CFR Regulation Number | 882.4525 [🔎] |
| Device Problems | |
|---|---|
Break | 8 |
Material Integrity Problem | 2 |
Tip | 2 |
Appropriate Term/Code Not Available | 1 |
Component Missing | 1 |
Bent | 1 |
Fracture | 1 |
Device Operates Differently Than Expected | 1 |
Device Or Device Fragments Location Unknown | 1 |
Insufficient Information | 1 |
Component Falling | 1 |
Mechanical Jam | 1 |
| Total Device Problems | 21 |