FDA 510(k)

ArtiSential 刺孔器

K号: K212500 · 2021-12-03

决定日期2021-12-03

产品代码GCJ

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决定实质等同

器械摘要

ArtiSential Trocar is the device name listed in this FDA 510(k) record. The listed applicant is Livsmed, Inc.. It received FDA 510(k) clearance on 2021-12-03 under 510(k) number K212500. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ArtiSential Trocar?

ArtiSential Trocar is a medical device that received FDA 510(k) clearance on 2021-12-03. The listed applicant is Livsmed, Inc.. The 510(k) number is K212500.

When did ArtiSential Trocar receive FDA 510(k) clearance?

ArtiSential Trocar received FDA 510(k) clearance on 2021-12-03, under 510(k) number K212500.

Who is the listed applicant for ArtiSential Trocar?

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 Trocar?

The FDA product code for ArtiSential Trocar is GCJ.

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：GCJ）

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。

K262397CuratOR EX2742Eizo Corporation K260884UNIDRIVE选择系统Karl Storz SE & CO. KG K260972OEV-271MUH 液晶显示器；OEV-321MUH 液晶显示器；OEV-431MUH 液晶显示器Sony Corporation K261139VereSee（VER150、VER200、VER151、VER201、VER200C和VER-100-103）Freyja Healthcare, LLC K253541EZ-Close™（EZ Close 端口部位闭合装置，EZ Close MAX 端口部位闭合装置，EZ Close II 端口部位闭合装置）Medical Impact K261614LED液晶显示器（OEV-271H）Lg Electronics.Inc

官方来源

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