| Device Type ID | 3667 |
| Device Name | Cover, Burr Hole |
| Regulation Description | Burr Hole Cover. |
| 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 | 882.5250 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GXR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3667 |
| Device | Cover, Burr Hole |
| Product Code | GXR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Burr Hole Cover. |
| CFR Regulation Number | 882.5250 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ABBOTT LABORATORIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEOS SURGERY S.L. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEUROPACE INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OSSDSIGN AB | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ST JUDE MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ST. JUDE MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Break | 26 |
Adverse Event Without Identified Device Or Use Problem | 20 |
Activation, Positioning Or Separation Problem | 8 |
Unstable | 5 |
Device Operates Differently Than Expected | 4 |
Device Or Device Fragments Location Unknown | 3 |
Unintended Movement | 3 |
Insufficient Information | 2 |
Loose Or Intermittent Connection | 2 |
Difficult To Open Or Close | 2 |
Shipping Damage Or Problem | 1 |
Component Missing | 1 |
Device Component Or Accessory | 1 |
Material Integrity Problem | 1 |
Product Quality Problem | 1 |
Shelf Life Exceeded | 1 |
Clamp | 1 |
Material Fragmentation | 1 |
| Total Device Problems | 83 |