| Device Type ID | 5693 |
| Device Name | Electrode, 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 | JOS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 5693 |
| Device | Electrode, Electrosurgical |
| Product Code | JOS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electrosurgical Cutting And Coagulation Device And Accessories. |
| CFR Regulation Number | 878.4400 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
OLYMPUS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OLYMPUS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Material Fragmentation | 4 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Break | 3 |
Device Handling Problem | 2 |
Sparking | 2 |
Device Operational Issue | 1 |
Material Twisted / Bent | 1 |
Cable | 1 |
Fire | 1 |
Fracture | 1 |
Difficult To Remove | 1 |
Melted | 1 |
Use Of Device Problem | 1 |
Ring | 1 |
Detachment Of Device Component | 1 |
Material Deformation | 1 |
Excessive Heating | 1 |
Mechanical Problem | 1 |
Overheating Of Device | 1 |
Insufficient Information | 1 |
Grounding Malfunction | 1 |
| Total Device Problems | 31 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | ConMed Corporation | II | Oct-14-2016 |