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 |