# K162047: LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated

- Pathway: 510(k) (Special)
- Applicant: Covidien
- Decided: Sep 15, 2016 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: 7 generations back to K932293 (1994). 22 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123444: Ligasure Impact Curved, Large Jaw, Open Sealer / Divider, Covidien, Formerly Valleylab, A Division of Tyco H (2013) Summary page 4.
- K141153: Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider, Maryland Jaw One Step Stealer/Dividers, Curved, Covidien (2014) Summary page 4.

## Most influential descendants
- K181085: LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated (2018), 1 descendant of its own
- K252487: POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) (2026), 0 descendants of its own
- K231732: CleanSeal Advanced Bipolar Vessel Sealer Maryland (2023), 0 descendants of its own

## Indications for use
The LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/ Divider can be used on vessels (arteries, veins, pulmonary arteries, pulmonary veins) up to and including 7 mm. It is indicated for use in general surgery and such surgical specialties as urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, etc. The LigaSure 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/K162047
Methodology: https://510kreport.com/methodology