The following data is part of a premarket notification filed by Medtronic Advanced Energy with the FDA for Aex Generator; Plasmablade T.
Device ID | K143175 |
510k Number | K143175 |
Device Name: | AEx Generator; PlasmaBlade T |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | MEDTRONIC ADVANCED ENERGY 180 INTERNATIONAL DRIVE Portsmouth, NH 03801 |
Contact | Deep Pal |
Correspondent | Deep Pal 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 | 2014-11-04 |
Decision Date | 2014-12-31 |
Summary: | summary |