FDA 510(k)

達芬奇手術系統 (IS5000)

K 號：K251739 · 2026-01-16

決定日期2026-01-16

產品代碼NAY

諮詢委員會GU

決定相當於

器材摘要

da Vinci Surgical System (IS5000) is the device name listed in this FDA 510(k) record. The listed applicant is Intuitive Surgical, Inc.. It received FDA 510(k) clearance on 2026-01-16 under 510(k) number K251739. 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 Surgical System (IS5000)?

da Vinci Surgical System (IS5000) is a medical device that received FDA 510(k) clearance on 2026-01-16. The listed applicant is Intuitive Surgical, Inc.. The 510(k) number is K251739.

When did da Vinci Surgical System (IS5000) receive FDA 510(k) clearance?

da Vinci Surgical System (IS5000) received FDA 510(k) clearance on 2026-01-16, under 510(k) number K251739.

Who is the listed applicant for da Vinci Surgical System (IS5000)?

FDA 510(k) 記錄將 Intuitive Surgical, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for da Vinci Surgical System (IS5000)?

The FDA product code for da Vinci Surgical System (IS5000) is NAY.

其他以 Intuitive Surgical, 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。

K261823達芬奇手術系統，型號IS5000 K253702直觀內腔結腸胃腸系統（IG1000）K261824達芬奇手術系統，型號IS5000 K261249通用密封 (5-12 毫米)K253986da Vinci Force Feedback Instruments K253978通用密封 (5-12 毫米)

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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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