The following data is part of a premarket notification filed by Covidien with the FDA for Valleylab Ft10 Electrosurgical Platform.
| Device ID | K191601 |
| 510k Number | K191601 |
| Device Name: | Valleylab FT10 Electrosurgical Platform |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Covidien 5920 Longbow Drive Boulder, CO 80301 |
| Contact | Jennie Van Diemen |
| Correspondent | Jennie Van Diemen Covidien 5920 Longbow Drive Boulder, CO 80301 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-17 |
| Decision Date | 2019-07-12 |