FDA 510(k)

Canady Helios 冷等离子體™ XL-1000CP™ 消融系統 (XL-1000CPSYS)

K 號：K240297 · 2024-05-03

決定日期2024-05-03

產品代碼OAB

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS) is the device name listed in this FDA 510(k) record. The listed applicant is Us Medical Innovations, LLC. It received FDA 510(k) clearance on 2024-05-03 under 510(k) number K240297. 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 Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)?

Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS) is a medical device that received FDA 510(k) clearance on 2024-05-03. The listed applicant is Us Medical Innovations, LLC. The 510(k) number is K240297.

When did Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS) receive FDA 510(k) clearance?

Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS) received FDA 510(k) clearance on 2024-05-03, under 510(k) number K240297.

Who is the listed applicant for Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)?

The FDA 510(k) record lists Us Medical Innovations, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)?

The FDA product code for Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS) is OAB.

其他以 Us Medical Innovations, LLC 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。

K212736Canady Flex 電動手腕 K192124Canady Plasma SMART XL-1000 電外科電流發生器及配件

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)Angiodynamics K242687NanoKnife 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.K233884INUMI™ 強針Galvanize Therapeutics, Inc.

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。