| Device Type ID | 3711 |
| Device Name | Clip, Scalp |
| Regulation Description | Scalp Clip. |
| 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 | 882.4150 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HBO |
| 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 | 3711 |
| Device | Clip, Scalp |
| Product Code | HBO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Scalp Clip. |
| CFR Regulation Number | 882.4150 [🔎] |
| Device Problems | |
|---|---|
Device Contamination With Chemical Or Other Material | 6 |
Incorrect Device Or Component Shipped | 5 |
Packaging Problem | 3 |
Break | 1 |
Crack | 1 |
Device-Device Incompatibility | 1 |
Component Missing | 1 |
Appropriate Term/Code Not Available | 1 |
Failure To Eject | 1 |
| Total Device Problems | 20 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Medtronic Neurosurgery | II | Sep-21-2018 |
| 2 | Medtronic Neurosurgery | II | Feb-15-2018 |