FDA 510(k)

增強外科系統

K 號：K183098 · 2018-12-06

決定日期2018-12-06

產品代碼NAY

諮詢委員會GU

決定相當於

器材摘要

Senhance Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is Transenterix, Inc.. It received FDA 510(k) clearance on 2018-12-06 under 510(k) number K183098. 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 Senhance Surgical System?

Senhance Surgical System is a medical device that received FDA 510(k) clearance on 2018-12-06. The listed applicant is Transenterix, Inc.. The 510(k) number is K183098.

When did Senhance Surgical System receive FDA 510(k) clearance?

Senhance Surgical System received FDA 510(k) clearance on 2018-12-06, under 510(k) number K183098.

Who is the listed applicant for Senhance Surgical System?

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

What is the FDA product code for Senhance Surgical System?

The FDA product code for Senhance Surgical System is NAY.

其他以 Transenterix, Inc. 為申請人之記錄

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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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