FDA 510(k)

Canady Helios 冷等离子体™ XL-1000CP™ 消融系统 (XL-1000CPSYS)

K号: K240297 · 2024-05-03

决定日期2024-05-03

产品代码OAB

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决定实质等同

器械摘要

Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS) is the device name listed in this FDA 510(k) record. The listed applicant is Us Medical Innovations, LLC. It received FDA 510(k) clearance on 2024-05-03 under 510(k) number K240297. The device is classified under product code OAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)?

Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS) is a medical device that received FDA 510(k) clearance on 2024-05-03. The listed applicant is Us Medical Innovations, LLC. The 510(k) number is K240297.

When did Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS) receive FDA 510(k) clearance?

Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS) received FDA 510(k) clearance on 2024-05-03, under 510(k) number K240297.

Who is the listed applicant for Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)?

The FDA 510(k) record lists Us Medical Innovations, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)?

The FDA product code for Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS) is OAB.

列明Us Medical Innovations, LLC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。

K212736Canady Flex RoboWrist K192124Canady Plasma SMART XL-1000 电外科发生器及附件

相关器械（代码：OAB）

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。

K253846陡脉冲消融仪（包括一次性无菌陡脉冲探头）（SPA-C02）；一次性无菌陡脉冲探头（NPA-DJ01）；探头连接线（NPA-LX-02）Hangzhou Ruidi Biotechnology , Ltd.K253826Aliya® EX 系统；Aliya® EX 发电机；Aliya® 针；Aliya® 电极；INUMI™ 弹性针Galvanize Therapeutics, Inc.K253198NanoKnife发生器（H78720300351US0）Angiodynamics K242687NanoKnife发生器（H78720300301US0）；NanoKnife单电极激活探头，15厘米（H787204001090）；NanoKnife单电极激活探头，25厘米（H787204001100）；NanoKnife单电极探头间隔器（H787204003010）AngioDynamics, Inc.K240376电穿孔系统（N3000）Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.K233884INUMI™ Flex NeedleGalvanize Therapeutics, Inc.

官方来源

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