Definition: Intended For Any Procedure Where Vessel Ligation (cutting And Sealing), Soft Tissue Grasping And Dissection Are Performed.
| Device Type ID | 5859 |
| Device Name | Electrosurgical Vessel And/or Tissue Sealer. With Built-in Generator. |
| Physical State | Applicator/Dissector, RF Generator And Battery Are Integrated In A Single Handpiece. |
| Technical Method | Application Of RF Energy To Heat And Seal Vessel/tissue Followed By Dissection Of Target Vessel/tissue. |
| Target Area | Has Not Been Shown To Be Effective For Tubal Sterilization Or Tubal Coagulation For Sterilization Procedures. |
| 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 | PDG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5859 |
| Device | Electrosurgical Vessel And/or Tissue Sealer. With Built-in Generator. |
| Product Code | PDG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electrosurgical Cutting And Coagulation Device And Accessories. |
| CFR Regulation Number | 878.4400 [🔎] |