Device Type ID | 5694 |
Device Name | Electrode, Gel, 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) Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1) |
Submission Type | 510(k) |
CFR Regulation Number | 878.4400 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | JOT |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Program |
Device Type ID | 5694 |
Device | Electrode, Gel, Electrosurgical |
Product Code | JOT |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Electrosurgical Cutting And Coagulation Device And Accessories. |
CFR Regulation Number | 878.4400 [🔎] |