FDA 510(k)

達芬奇Xi外科系統（IS4000）；達芬奇X外科系統（IS4200）

K 號：K240723 · 2024-05-24

決定日期2024-05-24

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 (IS4000); da Vinci X Surgical System (IS4200) is the device name listed in this FDA 510(k) record. The listed applicant is Intuitive Surgical. It received FDA 510(k) clearance on 2024-05-24 under 510(k) number K240723. 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 (IS4000); da Vinci X Surgical System (IS4200)?

da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) is a medical device that received FDA 510(k) clearance on 2024-05-24. The listed applicant is Intuitive Surgical. The 510(k) number is K240723.

When did da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) receive FDA 510(k) clearance?

da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) received FDA 510(k) clearance on 2024-05-24, under 510(k) number K240723.

Who is the listed applicant for da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)?

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 (IS4000); da Vinci X Surgical System (IS4200)?

The FDA product code for da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) is NAY.

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）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 K192803達芬奇Xi外科系統，達芬奇X外科系統

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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 Surgical K254192昇強超聲波系統Asensus Surgical K253986da 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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