# K150835: LigaSure Advance Monopolar Tip Laparoscopic Sealer/Divider, Pistol Grip

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Oct 15, 2015 after 199 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.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063195: Ligasure Advance Laparoscopic Sealer/Divider with Dissecting Electrode, Models LF5034 and LF5044, Valleylab (2006) Summary page 4.

## Most influential descendants
- K161804: LigaSure Retractable L-Hook Laparoscopic Sealer/Divider (2016), 0 descendants of its own

## Indications for use
The LigaSure Advance Sealer/Divider is a bipolar/monopolar electrosurgical instrument intended for use in minimally invasive surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Advance Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. The instrument can be used to dissect through tissuc planes and to create enterotomies or gastrotomies. It is indicated for use in gencral surgery and such surgical specialties as urologic, vascular, thoracic, colorectal, bariatric, and gynecologic. Procedures may include, but are not limited to, gastric bypass, 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 stetilization procedures. Do not use the LigaSure system for these procedures.

Source page: https://510kreport.com/device/K150835
Methodology: https://510kreport.com/methodology