FDA 510(k)

ArtiSential 双极带孔镊子

K号: K190909 · 2020-02-13

决定日期2020-02-13

产品代码GEI

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决定实质等同

器械摘要

ArtiSential Bipolar Fenestrated Forceps is the device name listed in this FDA 510(k) record. The listed applicant is Livsmed, Inc.. It received FDA 510(k) clearance on 2020-02-13 under 510(k) number K190909. 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 ArtiSential Bipolar Fenestrated Forceps?

ArtiSential Bipolar Fenestrated Forceps is a medical device that received FDA 510(k) clearance on 2020-02-13. The listed applicant is Livsmed, Inc.. The 510(k) number is K190909.

When did ArtiSential Bipolar Fenestrated Forceps receive FDA 510(k) clearance?

ArtiSential Bipolar Fenestrated Forceps received FDA 510(k) clearance on 2020-02-13, under 510(k) number K190909.

Who is the listed applicant for ArtiSential Bipolar Fenestrated Forceps?

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 ArtiSential Bipolar Fenestrated Forceps?

The FDA product code for ArtiSential Bipolar Fenestrated Forceps 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。

查看所有 12 个设备 →

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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