FDA 510(k)

Sistema de Sellado de Vasos ArtiSeal - Instrumentos ArtiSeal (AS01M)

N.º K: K250126 · 2025-10-21

Fecha de decisión2025-10-21

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) is the device name listed in this FDA 510(k) record. The listed applicant is Livsmed, Inc.. It received FDA 510(k) clearance on 2025-10-21 under 510(k) number K250126. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)?

ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) is a medical device that received FDA 510(k) clearance on 2025-10-21. The listed applicant is Livsmed, Inc.. The 510(k) number is K250126.

When did ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) receive FDA 510(k) clearance?

ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) received FDA 510(k) clearance on 2025-10-21, under 510(k) number K250126.

Who is the listed applicant for ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)?

The FDA 510(k) record lists Livsmed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)?

The FDA product code for ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) is GEI.

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Fuente oficial

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