The following data is part of a premarket notification filed by Medtronic Advanced Energy with the FDA for Minimally Invasive Sealer (mis) Flex, Minimally Invasive Sealer (mis) Flex Mini.
| Device ID | K170381 |
| 510k Number | K170381 |
| Device Name: | Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini |
| 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 | 2017-02-07 |
| Decision Date | 2017-09-07 |
| Summary: | summary |