# K070162: Forcetriad Electrosurgical Generator; Ligasure Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Valleylab,A Division of Tyco Healthcare Group LP
- Decided: Mar 6, 2007 after 48 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: 3 generations back to K932293 (1994). 8 ancestors in all.
102 later devices descend from it; 9 cite it directly.
0 of 111 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.

## Most influential descendants
- K123444: Ligasure Impact Curved, Large Jaw, Open Sealer / Divider (2013), 56 descendants of its own
- K141153: Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider, Maryland Jaw One Step Stealer/Dividers, Curved (2014), 40 descendants of its own
- K110268: Forcetriad Electrosurgical Generator (2011), 16 descendants of its own
- K152286: LigaSure Curved, Small Jaw, Open Sealer/Divider (2015), 14 descendants of its own
- K170869: LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated (2017), 11 descendants of its own

## Indications for use
The ForceTriadTM is a full-featured electrosurgical generator intended for open and laparoscopic surgical procedures where the surgeon requires electrosurgical cutting, coagulation, or vessel sealing (tissue fusion). 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. 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 LigaSure 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/K070162
Methodology: https://510kreport.com/methodology
