| Device Type ID | 3697 |
| Device Name | Instrument, Surgical, Non-powered |
| Regulation Description | Nonpowered Neurosurgical 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 | 882.4535 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | HAO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3697 |
| Device | Instrument, Surgical, Non-powered |
| Product Code | HAO |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Nonpowered Neurosurgical Instrument. |
| CFR Regulation Number | 882.4535 [🔎] |
| Device Problems | |
|---|---|
Break | 88 |
Degraded | 27 |
Material Integrity Problem | 4 |
Material Rupture | 4 |
Material Discolored | 3 |
Tear, Rip Or Hole In Device Packaging | 2 |
Fracture | 2 |
Device Operates Differently Than Expected | 2 |
Contamination / Decontamination Problem | 2 |
Detachment Of Device Or Device Component | 2 |
Insufficient Information | 2 |
Material Deformation | 2 |
Material Fragmentation | 2 |
Unintended Movement | 1 |
Difficult To Open Or Remove Packaging Material | 1 |
Entrapment Of Device | 1 |
Imprecision | 1 |
Incorrect Measurement | 1 |
Component Missing | 1 |
Device Dislodged Or Dislocated | 1 |
Catheter | 1 |
Material Split, Cut Or Torn | 1 |
Difficult To Remove | 1 |
Failure To Adhere Or Bond | 1 |
| Total Device Problems | 153 |