| Device Type ID | 5666 |
| Device Name | Apparatus, Electrosurgical |
| Regulation Description | Electrosurgical Cutting And Coagulation Device And Accessories. |
| 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) |
| CFR Regulation Number | 878.4400 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HAM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 5666 |
| Device | Apparatus, Electrosurgical |
| Product Code | HAM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electrosurgical Cutting And Coagulation Device And Accessories. |
| CFR Regulation Number | 878.4400 [🔎] |
| Device Problems | |
|---|---|
Packaging Problem | 4 |
Tear, Rip Or Hole In Device Packaging | 2 |
Fire | 1 |
Sparking | 1 |
Delivered As Unsterile Product | 1 |
Self-Activation Or Keying | 1 |
Detachment Of Device Component | 1 |
| Total Device Problems | 11 |