# K162941: Ligasure Blunt Tip, Sealer/Divider, Nano-coated

- Pathway: 510(k) (Special)
- Applicant: Covidien
- Decided: Nov 14, 2016 after 24 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K932293 (1994). 23 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130744: Ligasure 5MM Blunt Tip Laparoscopic Sealer/Divider, Covidien (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.
- K142929: Ligasure Blunt Tip Sealer/Divider, Covidien (2015) Summary page 4.

## Most influential descendants
- K241138: ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing System-ArtiSeal Generator (2024), 1 descendant of its own
- K223158: LigaSure™ XP Maryland Jaw Sealer/Divider (2023), 1 descendant of its own
- K260636: Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating (2026), 0 descendants of its own
- K250126: ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) (2025), 0 descendants of its own

## Recalls of this device
- Dec 6, 2021 · Class II · Z-0495-2022: Customers reported that the device jaws were difficult to open or would not open following application on tissue. Use of a device with this potential assembly issue could result in the potential for b

## Indications for use
The LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or 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 and 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/K162941
Methodology: https://510kreport.com/methodology