| Device Type ID | 3695 |
| Device Name | Rongeur, Powered |
| Regulation Description | Powered Rongeur. |
| 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 | 882.4845 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HAD |
| 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 | 3695 |
| Device | Rongeur, Powered |
| Product Code | HAD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Powered Rongeur. |
| CFR Regulation Number | 882.4845 [🔎] |
| Device Problems | |
|---|---|
Break | 15 |
Detachment Of Device Or Device Component | 5 |
Use Of Device Problem | 3 |
Difficult To Open Or Close | 2 |
Shaft | 1 |
Jaw | 1 |
Bent | 1 |
Physical Resistance | 1 |
Mechanical Problem | 1 |
Component Falling | 1 |
Detachment Of Device Component | 1 |
Air Leak | 1 |
| Total Device Problems | 33 |