# K051644: Valleylab Forcetriad Electrosurgical Generator

- Pathway: 510(k) (Traditional)
- Applicant: Valleylab
- Decided: Aug 11, 2005 after 52 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: 2 generations back to K932293 (1994). 7 ancestors in all.
128 later devices descend from it; 7 cite it directly.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944602: Valleylab Force FX, Valleylab, Inc. (1995) Summary page 1.
- K981916: Ligasure Vessel Sealing System, Valleylab, Inc. (1998) Summary page 1.

## Most influential descendants
- K070162: Forcetriad Electrosurgical Generator; Ligasure Instruments (2007), 102 descendants of its own
- 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
- K081129: Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, Etrio-314D,-325D,-335D,-345D, Enseal Universal (2008), 24 descendants of its own
- K171262: TempSure (2017), 16 descendants of its own

## Indications for use
The indications for use include general (including urologic, thoracic, plastic and reconstructive, arthroscopic), laparoscopic, and gynecologic procedures where electrosurgical cutting and coagulation of tissue, and sealing (fusion) of 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. Vessels (arteries, veins, fitlymph) 7mm and smaller in diameter, and bundles as large as will in the jaws of the devices can be sealed with the LigaSure vessel sealing (tissue fusion) output.

Source page: https://510kreport.com/device/K051644
Methodology: https://510kreport.com/methodology