| Device Type ID | 5487 |
| Device Name | Unit, Electrosurgical And Coagulation, With Accessories |
| 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 | BWA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 5487 |
| Device | Unit, Electrosurgical And Coagulation, With Accessories |
| Product Code | BWA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electrosurgical Cutting And Coagulation Device And Accessories. |
| CFR Regulation Number | 878.4400 [🔎] |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 5 |
Jaw | 4 |
Device Remains Activated | 4 |
Difficult To Open Or Close | 3 |
Tip | 2 |
Sticking | 2 |
Device Or Device Fragments Location Unknown | 2 |
Insufficient Information | 1 |
Crack | 1 |
Scratched Material | 1 |
Detachment Of Device Component | 1 |
Failure To Deliver Energy | 1 |
Material Separation | 1 |
Metal Shedding Debris | 1 |
Component Missing | 1 |
Self-Activation Or Keying | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Energy Output To Patient Tissue Incorrect | 1 |
Fire | 1 |
Sparking | 1 |
| Total Device Problems | 35 |