INUMI™ Flex Needle
K号: K233884 · 2024-05-22
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决定日期2024-05-22
产品代码OAB
咨询委员会SU
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决定实质等同
器械摘要
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 2024-05-22 under 510(k) number K233884. 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 INUMI™ Flex Needle?
INUMI™ Flex Needle is a medical device that received FDA 510(k) clearance on 2024-05-22. The listed applicant is Galvanize Therapeutics, Inc.. The 510(k) number is K233884.
When did INUMI™ Flex Needle receive FDA 510(k) clearance?
INUMI™ Flex Needle received FDA 510(k) clearance on 2024-05-22, under 510(k) number K233884.
Who is the listed applicant for 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 INUMI™ Flex Needle?
The FDA product code for INUMI™ Flex Needle is OAB.
相关临床试验
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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。
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）AngiodynamicsK242687NanoKnife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.K240297Canady Helios 冷等离子体™ XL-1000CP™ 消融系统 (XL-1000CPSYS)Us Medical Innovations, LLC
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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