| Device Type ID | 5662 |
| Device Name | Bit, Surgical |
| 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 One - Light Based/Laser (GSDB1) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4820 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GFG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5662 |
| Device | Bit, Surgical |
| Product Code | GFG |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Surgical Instrument Motors And Accessories/attachments. |
| CFR Regulation Number | 878.4820 [🔎] |
| Device Problems | |
|---|---|
Break | 44 |
Entrapment Of Device | 3 |
Material Fragmentation | 2 |
Fracture | 2 |
Device Operates Differently Than Expected | 2 |
Dull, Blunt | 1 |
Mechanical Problem | 1 |
| Total Device Problems | 55 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Smith & Nephew, Inc. | II | Apr-18-2017 |
| 2 | Synthes, Inc. | II | May-29-2014 |