FDA 510(k)

IS4000 鋼釘機 30 工具及釘針 30 製品重裝

K 號：K152421 · 2016-03-04

決定日期2016-03-04

產品代碼NAY

諮詢委員會GU

決定相當於

器材摘要

IS4000 Stapler 30 Instrument and Stapler 30 Reloads 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 2016-03-04 under 510(k) number K152421. 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 IS4000 Stapler 30 Instrument and Stapler 30 Reloads?

IS4000 Stapler 30 Instrument and Stapler 30 Reloads is a medical device that received FDA 510(k) clearance on 2016-03-04. The listed applicant is Intuitive Surgical, Inc.. The 510(k) number is K152421.

When did IS4000 Stapler 30 Instrument and Stapler 30 Reloads receive FDA 510(k) clearance?

IS4000 Stapler 30 Instrument and Stapler 30 Reloads received FDA 510(k) clearance on 2016-03-04, under 510(k) number K152421.

Who is the listed applicant for IS4000 Stapler 30 Instrument and Stapler 30 Reloads?

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 IS4000 Stapler 30 Instrument and Stapler 30 Reloads?

The FDA product code for IS4000 Stapler 30 Instrument and Stapler 30 Reloads 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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