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 |