# K172757: Valleylab FX8 Electrosurgical Platform

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Nov 2, 2017 after 50 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: 8 generations back to K911904 (1991). 31 ancestors in all.
6 later devices descend from it; 1 cites 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)
- K151649: Valleylab FT10 Electrosurgical Platform, Covidien (2015) Summary page 4.
- K170170: Valleylab FT10 Electrosurgical Platform, Covidien, LLC (2017) Summary page 4.

## Most influential descendants
- K181389: Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform (2018), 5 descendants of its own
- 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

## Indications for use
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/K172757
Methodology: https://510kreport.com/methodology