# K181389: Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform

- Pathway: 510(k) (Special)
- Applicant: Covidien
- Decided: Jun 19, 2018 after 25 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K911904 (1991). 32 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170170: Valleylab FT10 Electrosurgical Platform, Covidien, LLC (2017) Summary page 5.
- K172757: Valleylab FX8 Electrosurgical Platform, Covidien, LLC (2017) Summary page 5.

## Most influential descendants
- K182610: Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device (2018), 2 descendants of its own
- K241138: ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing System-ArtiSeal Generator (2024), 1 descendant of its own
- K191601: Valleylab FT10 Electrosurgical Platform (2019), 1 descendant of its own
- K250126: ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) (2025), 0 descendants of its own
- K241085: Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN) (2024), 0 descendants of its own

## Indications for use
The Valleylab FT10 Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics. The generator can also be used with compatible resectoscopes for endoscopically controlled removal or coagulation of tissue using 0.9% NaCl solution as the irrigation medium. The tissue fusion function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this function for these procedures. The Valleylab FX8 FX Series Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.

Source page: https://510kreport.com/device/K181389
Methodology: https://510kreport.com/methodology