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FDA 510(k)

達芬奇Xi外科系統，達芬奇X外科系統

K 號：K191529 · 2020-02-06

申請人Intuitive Surgical
決定日期2020-02-06
產品代碼NAY
諮詢委員會GU
決定相當於

器材摘要

da Vinci Xi Surgical System, da Vinci X Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is Intuitive Surgical. It received FDA 510(k) clearance on 2020-02-06 under 510(k) number K191529. The device is classified under product code NAY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the da Vinci Xi Surgical System, da Vinci X Surgical System?

da Vinci Xi Surgical System, da Vinci X Surgical System is a medical device that received FDA 510(k) clearance on 2020-02-06. The listed applicant is Intuitive Surgical. The 510(k) number is K191529.

When did da Vinci Xi Surgical System, da Vinci X Surgical System receive FDA 510(k) clearance?

da Vinci Xi Surgical System, da Vinci X Surgical System received FDA 510(k) clearance on 2020-02-06, under 510(k) number K191529.

Who is the listed applicant for da Vinci Xi Surgical System, da Vinci X Surgical System?

The FDA 510(k) record lists Intuitive Surgical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for da Vinci Xi Surgical System, da Vinci X Surgical System?

The FDA product code for da Vinci Xi Surgical System, da Vinci X Surgical System is NAY.

相關臨床試驗

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NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Intuitive Surgical 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。

K260695達芬奇火飛行影響系統K241635達芬奇 E-200 電外科電流發生器K241621達文西單極與雙極适配器（378896）K240723達芬奇Xi外科系統（IS4000）；達芬奇X外科系統（IS4200）K231212達芬奇 E-200 電外科電流發生器K223039達芬奇 E-200 電外科電流發生器

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相關器械（代碼：NAY）

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。

K261823達芬奇手術系統，型號IS5000Intuitive Surgical, Inc.K261824達芬奇手術系統，型號IS5000Intuitive Surgical, Inc.K260695達芬奇火飛行影響系統Intuitive SurgicalK254192昇強超聲波系統Asensus SurgicalK253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc.K253556達芬奇SP外科系統（SP1098）；達芬奇E-200發生器Intuitive Surgical, Inc.

官方來源

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