The following data is part of a premarket notification filed by Covidien with the FDA for Valleylab Ft10 Energy Platform, Valleylab Fx8 Fx Series Energy Platform.
| Device ID | K181389 |
| 510k Number | K181389 |
| Device Name: | Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Covidien 5920 Longbow Drive Boulder, CO 80301 |
| Contact | Celso Duran |
| Correspondent | Celso Duran 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 | 2018-05-25 |
| Decision Date | 2018-06-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521780408 | K181389 | 000 |
| 10884521780415 | K181389 | 000 |