# K191601: Valleylab FT10 Electrosurgical Platform

- Pathway: 510(k) (Special)
- Applicant: Covidien
- Decided: Jul 12, 2019 after 25 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K942299 (1995). 90 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182610: Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device, Medtronic (2018) Summary page 4.

## Most influential descendants
- K241085: Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN) (2024), 0 descendants of its own

## Recalls of this device
- Nov 16, 2023 · Class II · Z-0631-2024: Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in system being inoperable

## 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. When used with compatible ablation devices, it is indicated for cardiac tissue ablation. 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.

Source page: https://510kreport.com/device/K191601
Methodology: https://510kreport.com/methodology