# K161804: LigaSure Retractable L-Hook Laparoscopic Sealer/Divider

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Sep 16, 2016 after 78 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). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150835: LigaSure Advance Monopolar Tip Laparoscopic Sealer/Divider, Pistol Grip, Covidien (2015) Summary page 4.
- K063195: Ligasure Advance Laparoscopic Sealer/Divider with Dissecting Electrode, Models LF5034 and LF5044, Valleylab (2006) 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.
- K133338: Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX), Covidien, Formerly Valleylab, A Division of Tyco H (2013) Summary page 4.
- K904560: Valleylab Laparoscopic Handswitch/Electrodes, Valleylab, Inc. (1990) Summary page 4.

## Indications for use
The LigaSure Retractable L-Hook Laparoscopic Sealer/Divider is a 5mm 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 Sealer/Divider can be used on vessels (arteries and veins) up to and including 7mm in diameter. The monopolar L-Hook can be used to dissect through tissue planes and to create enterotomies or gastrotomies. It is indicated for use in general surgery and such surgical specialties as urologic, vascular, thoracic, colorectal, bariatric, and gynecologic. Procedures may include, but are not limited to, gastric bypass, hysterectomy, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, 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/K161804
Methodology: https://510kreport.com/methodology