FDA 510(k)

Aliya™ 系统，Aliya™ 发电机，Aliya™ 针，Aliya™ 电极

K号: K212871 · 2022-06-17

决定日期2022-06-17

产品代码OAB

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决定实质等同

器械摘要

Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Galvanize Therapeutics, Inc.. It received FDA 510(k) clearance on 2022-06-17 under 510(k) number K212871. 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 Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode?

Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode is a medical device that received FDA 510(k) clearance on 2022-06-17. The listed applicant is Galvanize Therapeutics, Inc.. The 510(k) number is K212871.

When did Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode receive FDA 510(k) clearance?

Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode received FDA 510(k) clearance on 2022-06-17, under 510(k) number K212871.

Who is the listed applicant for Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode?

The FDA 510(k) record lists Galvanize Therapeutics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode?

The FDA product code for Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode is OAB.

列明Galvanize Therapeutics, 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。

K253826Aliya® EX 系统；Aliya® EX 发电机；Aliya® 针；Aliya® 电极；INUMI™ 弹性针 K233884INUMI™ Flex Needle

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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