| Device Type ID | 3707 |
| Device Name | Drills, Burrs, Trephines & Accessories (manual) |
| Regulation Description | Manual 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 | 882.4300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HBG |
| 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 | 3707 |
| Device | Drills, Burrs, Trephines & Accessories (manual) |
| Product Code | HBG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Manual Cranial Drills, Burrs, Trephines, And Their Accessories |
| CFR Regulation Number | 882.4300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
FLEXTRONICS INTERNATIONAL USA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MRI INTERVENTIONS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Appropriate Term/Code Not Available | 3 |
Obstruction Of Flow | 1 |
Tip | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Material Integrity Problem | 1 |
False Reading From Device Non-Compliance | 1 |
Unintended Movement | 1 |
Break | 1 |
Overheating Of Device | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
| Total Device Problems | 12 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Instrumed International, Inc. | II | Dec-16-2014 |
| 2 | Integra LifeSciences Corp. D.b.a. Integra Pain Management | II | Sep-02-2016 |