| Device Type ID | 5661 |
| Device Name | Bur, Surgical, General & Plastic Surgery |
| Regulation Description | Surgical Instrument Motors And Accessories/attachments. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4820 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GFF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5661 |
| Device | Bur, Surgical, General & Plastic Surgery |
| Product Code | GFF |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Surgical Instrument Motors And Accessories/attachments. |
| CFR Regulation Number | 878.4820 [🔎] |
| Device Problems | |
|---|---|
Break | 94 |
Bent | 29 |
Overheating Of Device | 17 |
Tip | 10 |
Device Operates Differently Than Expected | 5 |
Fracture | 4 |
Vibration | 4 |
Detachment Of Device Component | 4 |
Material Deformation | 3 |
Material Fragmentation | 3 |
Fluid Leak | 3 |
Material Twisted / Bent | 3 |
Device Inoperable | 2 |
Handpiece | 2 |
Bearings | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Mechanical Problem | 2 |
Detachment Of Device Or Device Component | 2 |
Component Falling | 2 |
Material Separation | 2 |
Device Packaging Compromised | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Disconnection | 1 |
Difficult To Insert | 1 |
Loose Or Intermittent Connection | 1 |
Malposition Of Device | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Failure To Shut Off | 1 |
No Fail-Safe Mechanism | 1 |
Temperature Problem | 1 |
Difficult To Position | 1 |
Shaft | 1 |
Loss Of Or Failure To Bond | 1 |
Melted | 1 |
Device Dislodged Or Dislocated | 1 |
Activation Problem | 1 |
Material Discolored | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
| Total Device Problems | 213 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | ConMed Corporation | II | May-31-2016 |
| 2 | EXP Pharmaceutical Services Corp | II | Jul-24-2015 |
| 3 | The Anspach Effort, Inc. | II | May-04-2017 |
| 4 | The Anspach Effort, Inc. | II | Jan-27-2014 |
| 5 | The Anspach Effort, Inc. | II | Jan-06-2014 |