# K160331: LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable Clamp

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Aug 12, 2016 after 186 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: 8 generations back to K932293 (1994). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043273: Ligasure Vessel Sealing System. Ligasure Instruments, Valleylab (2005) Summary page 5.
- K981916: Ligasure Vessel Sealing System, Valleylab, Inc. (1998) Summary page 5.
- K152286: LigaSure Curved, Small Jaw, Open Sealer/Divider, Covidien (2015) Summary page 5.
- K141153: Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider, Maryland Jaw One Step Stealer/Dividers, Curved, Covidien (2014) Summary page 5.
- K113572: Ligasure Curved, Small Jaw, Open Sealer/Divider, Covidien, Formerly Valleylab, A Division of Tyco H (2012) Summary page 5.
- K102470: Lugasure Curved, Small Jaw, Open Sealer/Divider, Covidien, Formerly Valleylab, (2011) Summary page 5.

## Indications for use
The LigaSure Sealer/Divider, comprised of a single use electrode and a reusable clamp, is intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Electrode is a single use component that attaches to the LigaSure Clamp. After assembly, the LigaSure Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, reconstructive, and gynecologic. Procedures may include, but are not limited to, bowel resections, hysterectomy, oophorectomy, gall bladder procedures, Nissen fundoplication, and adhesiolysis. 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. The LigaSure Sealer/Divider, comprised of a single use electrode and a reusable clamp, is intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Clamp is a reusable handpiece to which the LigaSure Electrode attaches. Refer to the labeling of the compatible electrode for specific indications. 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/K160331
Methodology: https://510kreport.com/methodology