The following data is part of a premarket notification filed by Medtronic Advanced Energy with the FDA for Plasmablade Uppp And Suction Coagulator.
Device ID | K150297 |
510k Number | K150297 |
Device Name: | PlasmaBlade UPPP And Suction Coagulator |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | MEDTRONIC ADVANCED ENERGY 180 INTERNATIONAL DRIVE Portsmouth, NH 03801 |
Contact | Lydia Sakakeeny |
Correspondent | Lydia Sakakeeny 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 | 2015-02-06 |
Decision Date | 2015-05-21 |
Summary: | summary |