FDA 510(k)

Aliya® EX 系统；Aliya® EX 发电机；Aliya® 针；Aliya® 电极；INUMI™ 弹性针

K号: K253826 · 2026-05-07

决定日期2026-05-07

产品代码OAB

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决定实质等同

器械摘要

Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle 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 2026-05-07 under 510(k) number K253826. 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® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle?

Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle is a medical device that received FDA 510(k) clearance on 2026-05-07. The listed applicant is Galvanize Therapeutics, Inc.. The 510(k) number is K253826.

When did Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle receive FDA 510(k) clearance?

Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle received FDA 510(k) clearance on 2026-05-07, under 510(k) number K253826.

Who is the listed applicant for Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle?

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® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle?

The FDA product code for Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle 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。

K233884INUMI™ Flex Needle K212871Aliya™ 系统，Aliya™ 发电机，Aliya™ 针，Aliya™ 电极

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.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.K240297Canady Helios 冷等离子体™ XL-1000CP™ 消融系统 (XL-1000CPSYS)Us Medical Innovations, LLC

官方来源

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