The following data is part of a premarket notification filed by Medtronic Advanced Energy with the FDA for Plasmablade X 3.0s, Plasmablade X 4.0.
| Device ID | K181257 |
| 510k Number | K181257 |
| Device Name: | PlasmaBlade X 3.0S, PlasmaBlade X 4.0 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Medtronic Advanced Energy 180 International Drive Portsmouth, NH 03801 |
| Contact | Heather Valley |
| Correspondent | Heather Valley Medtronic Advanced Energy 180 International Drive Portsmouth, NH 03801 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-11 |
| Decision Date | 2018-08-02 |