| Device Type ID | 3706 |
| Device Name | Drills, Burrs, Trephines & Accessories (compound, Powered) |
| Regulation Description | Powered Compound Cranial Drills, Burrs, Trephines, And Their Accessories. |
| 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 | 882.4305 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HBF |
| 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 | 3706 |
| Device | Drills, Burrs, Trephines & Accessories (compound, Powered) |
| Product Code | HBF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Powered Compound Cranial Drills, Burrs, Trephines, And Their Accessories. |
| CFR Regulation Number | 882.4305 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
INTEGRA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INTEGRA LIFESCIENCES CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MICROMAR IND. COM. LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Failure To Auto Stop | 241 |
Dull, Blunt | 35 |
Adverse Event Without Identified Device Or Use Problem | 23 |
Device Remains Activated | 21 |
Use Of Device Problem | 20 |
Mechanical Problem | 8 |
Insufficient Information | 7 |
Device Operational Issue | 5 |
Fracture | 4 |
Appropriate Term/Code Not Available | 4 |
Peeled / Delaminated | 4 |
Device Contamination With Chemical Or Other Material | 4 |
Material Fragmentation | 4 |
Plunge | 4 |
Disconnection | 3 |
Metal Shedding Debris | 3 |
Fail-Safe Problem | 3 |
Difficult To Remove | 3 |
Device Issue | 2 |
Loss Of Power | 1 |
Material Separation | 1 |
Unsealed Device Packaging | 1 |
Unintended Movement | 1 |
Flaked | 1 |
Break | 1 |
Failure To Sense | 1 |
Device Operates Differently Than Expected | 1 |
Application Interface Becomes Non-Functional Or Program Exits Abnormally | 1 |
Material Discolored | 1 |
| Total Device Problems | 408 |