| Device Type ID | 5491 |
| Device Name | Blade, Saw, Surgical, Cardiovascular |
| 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 | DWH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5491 |
| Device | Blade, Saw, Surgical, Cardiovascular |
| Product Code | DWH |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Surgical Instrument Motors And Accessories/attachments. |
| CFR Regulation Number | 878.4820 [🔎] |
| Device Problems | |
|---|---|
Break | 10 |
Cutter | 1 |
| Total Device Problems | 11 |