# K110268: Forcetriad Electrosurgical Generator

- Pathway: 510(k) (Traditional)
- Applicant: Covidien Lp, Formerly Know AS Valleylab, A Divison
- Decided: May 31, 2011 after 123 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: 5 generations back to K911904 (1991). 28 ancestors in all.
16 later devices descend from it; 3 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051644: Valleylab Forcetriad Electrosurgical Generator, Valleylab (2005) Summary page 1.
- K070162: Forcetriad Electrosurgical Generator; Ligasure Instruments, Valleylab,A Division of Tyco Healthcare Group LP (2007) Summary page 1.
- K060484: Erbe Vio Esu, Model Vio 300 D, Erbe USA, Inc. (2006) Summary page 1.
- K062464: Modification to Autocon II 400 Electrosurgical Generator, KARL STORZ Endoscopy-America, Inc. (2007) Summary page 1.
- K100816: PK Superpulse Sysem Generator Model 744000, Gyrus Acmi, Inc. (2010) Summary page 1.

## Most influential descendants
- K151649: Valleylab FT10 Electrosurgical Platform (2015), 10 descendants of its own
- K170170: Valleylab FT10 Electrosurgical Platform (2017), 8 descendants of its own
- K172757: Valleylab FX8 Electrosurgical Platform (2017), 6 descendants of its own
- K181389: Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform (2018), 5 descendants of its own
- K223039: da Vinci E-200 Electrosurgical Generator (2022), 3 descendants of its own

## Indications for use
The ForceTriad is a full-featured electrosurgical generator intended for open and laparoscopic surgical procedures where the surgeon requires electrosurgical cutting (resecting, dividing, or separating), coagulation (hemostasis, coagulating, or desiccating), or vessel sealing (sealing or fusing,). The generator is intended for use in general, laparoscopic, and gynecologic surgical procedures where ligation of vessels, pulmonary vasculature, or lymph vessels, is desired. The system creates a vessel ligation (seal) by the application of bipolar electrosurgical RF energy (coagulation) to vessels interposed between the jaws of the device. The generator can also be used with standard bipolar devices where bipolar cutting or coagulation is desired or with compatible resectoscopes for endloscopically controlled removal (resection) or coagulation of tissue using 0.9% NaCI solution (saline) as the irrigation medium. The indications for use include general (including urologic, thoracic, plastic, and reconstructive), laparoscopic, and gynecological procedures where electrosurgical cutting and coagulation of tissue, and sealing (fusion) of vessels, including pulmonary vessels, and tissue bundles is performed, including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopic cholesystectomies, laparoscopically assisted vaginal hysterectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomy, etc. The devices can be used on vessels (arteries, veins, pulmonary arteries, pulmonary veins, lymph) up to 7mm and bundles as large as will fit in the jaws of the instruments. The LigaSdre 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/K110268
Methodology: https://510kreport.com/methodology