FDA 510(k)

ArtiSeal 血管封闭系统 - ArtiSeal 仪器 (AS01M)

K号: K250126 · 2025-10-21

决定日期2025-10-21

产品代码GEI

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决定实质等同

器械摘要

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.

常见问题

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.

列明Livsmed, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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相关器械（代码：GEI）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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