Definition: Ground Pad Used To Finish Circuit During Electrosurgery. A Single Use, Non-sterile Dispersive Electrode With A Pre-attached Cord Used To Adhere To The Patient Over The Entire Pad Surface To Complete The Electrosurgical Circuit Between The Generator,
| Device Type ID | 5794 |
| Device Name | Electrosurgical Patient Return Electrode |
| Physical State | The Electrode Consists Of Five Distinct Layers Of Materials: The Mylar (protective Cover) Which Is Removed Prior To Use, Gel, Aluminum, Acrylic Adhesive And Blue Foam. The Electrode Construction Consists Of A Dual Aluminum Electrode Which Connects To |
| Technical Method | Electrosurgical Patient Return Electrode Is A Single Use, Non-sterile Disposable Electrode With And Without A Pre-attached Cord. The Use Is To Complete An Electrical Circuit During Electrosurgery Between The Generator, The Active Electrode, And An Pa |
| Target Area | Thigh |
| 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 | ODR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5794 |
| Device | Electrosurgical Patient Return Electrode |
| Product Code | ODR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electrosurgical Cutting And Coagulation Device And Accessories. |
| CFR Regulation Number | 878.4400 [🔎] |