INUMI™ 強針
K 號：K233884 · 2024-05-22
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器材摘要
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.
常見問題
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.
相關臨床試驗
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其他以 Galvanize Therapeutics, Inc. 為申請人之記錄
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
相關器械（代碼：OAB）
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
K253846陡坡脉冲消融儀（含一次性无菌陡坡脉冲探針）(SPA-C02)；一次性无菌陡坡脉冲探針（NPA-DJ01）；探針連接線（NPA-LX-02）Hangzhou Ruidi Biotechnology , Ltd.K253826Aliya® EX 系統；Aliya® EX 產生器；Aliya® 尖針；Aliya® 電極；INUMI™ 強韌針Galvanize Therapeutics, Inc.K253198Nano刀發生器 (H78720300351US0)AngiodynamicsK242687NanoKnife 產生器 (H78720300301US0)；NanoKnife 獨一電極啟動探針，15 cm (H787204001090)；NanoKnife 獨一電極啟動探針，25 cm (H787204001100)；NanoKnife 獨一電極探針間隔器 (H787204003010)AngioDynamics, Inc.K240376電穿孔系統（N3000）Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.K240297Canady Helios 冷等离子體™ XL-1000CP™ 消融系統 (XL-1000CPSYS)Us Medical Innovations, LLC
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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