# K241138: ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing System-ArtiSeal Generator

- Pathway: 510(k) (Traditional)
- Applicant: Livsmed, Inc.
- Decided: Nov 15, 2024 after 205 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: 10 generations back to K911904 (1991). 48 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162941: Ligasure Blunt Tip, Sealer/Divider, Nano-coated, Covidien (2016) Summary page 5.
- K181389: Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform, Covidien (2018) Summary page 5.

## Most influential descendants
- K250126: ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) (2025), 0 descendants of its own

## Indications for use
ArtiSeal Vessel Sealing System-ArtiSeal Instruments ArtiSeal Vessel Sealing System - ArtiSeal Instruments are a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation (sealing) and division (Cutting) of vessels and tissue bundles is desired. ArtiSeal Vessel Sealing System - ArtiSeal Instruments can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery. ArtiSeal Vessel Sealing System-ArtiSeal Generator The ArtiSeal Vessel Sealing System - ArtiSeal Generator is a high-frequency electrosurgical device used in conjunction with disposable hand-controlled electrosurgical instruments, known as ArtiSeal Instruments. It provides radiofrequency (RF) energy to ligate vessels and tissue bundles. This energy platform automatically detects the connected instrument and immediately performs safety and diagnostic functions for the instrument. It is indicated for use in general surgery.

Source page: https://510kreport.com/device/K241138
Methodology: https://510kreport.com/methodology