# K123444: Ligasure Impact Curved, Large Jaw, Open Sealer / Divider

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, Formerly Valleylab, A Division of Tyco H
- Decided: Jan 30, 2013 after 83 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: 4 generations back to K932293 (1994). 13 ancestors in all.
56 later devices descend from it; 7 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112033: Enseal G2 Tissus Sealers, Ethicon Endo-Sugery, LLC (2011) Summary page 1.
- K010013: Ligasure Laparoscopic Sealer Divider Model LS1100, Valleylab, Inc. (2001) Summary page 1.
- K070162: Forcetriad Electrosurgical Generator; Ligasure Instruments, Valleylab,A Division of Tyco Healthcare Group LP (2007) Summary page 1.

## Most influential descendants
- 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
- 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
- K160554: Enseal X1 Large Jaw Tissue Sealer (2016), 6 descendants of its own
- K142929: Ligasure Blunt Tip Sealer/Divider (2015), 6 descendants of its own

## Indications for use
The LigaSure ImpactT" Curved, Large Jaw, Open Sealer/Divider is a dedicated bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels is desired. The LigaSure Impact LF4318 is intended to be used with the ForceTriadM energy platform to cut and seal vessels, and to cut, grasp and dissect tissue during surgery. The indications for use include open procedures (general, urologic, vascular, thoracic, and gynecological) where ligation and division of vessels is performed. These procedures include vaginal hysterectomies, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy, etc. The LigaSure Impact LF4318 can be used on vessels (arteries, veins, pulmonary vasculature, and lymph) up to and including 7mm and tissue bundles. The LigaSure TM system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

Source page: https://510kreport.com/device/K123444
Methodology: https://510kreport.com/methodology