The following data is part of a premarket notification filed by Medtronic Navigation with the FDA for Plasmablade X 3.0s Light.
| Device ID | K193579 |
| 510k Number | K193579 |
| Device Name: | PlasmaBlade X 3.0S LIGHT |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Medtronic Navigation 826 Coal Creek Circle Louisville, CO 80027 |
| Contact | Gina Cunsolo |
| Correspondent | Gina Cunsolo Medtronic Navigation 826 Coal Creek Circle Louisville, CO 80027 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-23 |
| Decision Date | 2020-03-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000279189 | K193579 | 000 |
| 00763000279172 | K193579 | 000 |
| 00763000279165 | K193579 | 000 |
| 00643169936676 | K193579 | 000 |
| 00763000059811 | K193579 | 000 |
| 00643169936683 | K193579 | 000 |