The following data is part of a premarket notification filed by Medtronic Advanced Energy with the FDA for Plasmablade Tna Tonsil And Adenoid Dissection Device.
| Device ID | K152703 |
| 510k Number | K152703 |
| Device Name: | PlasmaBlade TnA Tonsil And Adenoid Dissection Device |
| 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 | 2015-09-21 |
| Decision Date | 2016-07-08 |
| Summary: | summary |