FDA 510(k)

不可逆电穿孔消融发生器，不可逆电穿孔探头

K号: K222001 · 2023-06-08

申请人Zhejiang Curaway Medical Technology Co., Ltd.

决定日期2023-06-08

产品代码OAB

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决定实质等同

器械摘要

Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Curaway Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-06-08 under 510(k) number K222001. 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 Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe?

Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe is a medical device that received FDA 510(k) clearance on 2023-06-08. The listed applicant is Zhejiang Curaway Medical Technology Co., Ltd.. The 510(k) number is K222001.

When did Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe receive FDA 510(k) clearance?

Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe received FDA 510(k) clearance on 2023-06-08, under 510(k) number K222001.

Who is the listed applicant for Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe?

FDA 510(k)记录将浙江科瑞威医疗科技有限公司列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe?

The FDA product code for Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe is OAB.

列明Zhejiang Curaway Medical Technology Co., Ltd.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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查看所有 7 个设备 →

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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