FDA 510(k)

Flex機械人系統及Flex大腸驅動器

K 號：K162330 · 2017-05-04

決定日期2017-05-04

產品代碼FDF

諮詢委員會GU

決定相當於

器材摘要

Flex Robotic System and Flex Colorectal Drive is the device name listed in this FDA 510(k) record. The listed applicant is Medrobotics Corporation. It received FDA 510(k) clearance on 2017-05-04 under 510(k) number K162330. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Flex Robotic System and Flex Colorectal Drive?

Flex Robotic System and Flex Colorectal Drive is a medical device that received FDA 510(k) clearance on 2017-05-04. The listed applicant is Medrobotics Corporation. The 510(k) number is K162330.

When did Flex Robotic System and Flex Colorectal Drive receive FDA 510(k) clearance?

Flex Robotic System and Flex Colorectal Drive received FDA 510(k) clearance on 2017-05-04, under 510(k) number K162330.

Who is the listed applicant for Flex Robotic System and Flex Colorectal Drive?

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

What is the FDA product code for Flex Robotic System and Flex Colorectal Drive?

The FDA product code for Flex Robotic System and Flex Colorectal Drive is FDF.

其他以 Medrobotics Corporation 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。

K172796Flex機械手臂系統及Flex經腹驅動器 K170453醫用機器設備規範文本翻譯： Medrobotics Flex 閃耀機器系統 K172036醫用機器設備規範文本翻譯： Medrobotics Flex 閃耀機器系統

相關器械（代碼：FDF）

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。

K260503翠龍1系統Neptune Medical, Inc.K261015單獨鏡頭大腸內視鏡系統Gi View, Ltd.K261587充氣保留裝置 (IRD) (11173-325-101)BPEndo, LLC K260423一次性內視鏡遠端附件Yangzhou Fartley Medical Instrument Technology Co., Ltd.K252457一次性遠端端 Tape 帽Shanghai SeeGen Photoelectric Technology Co., Ltd.K244029ROBOPERA (ER-R-002)；ROBOPERA (ER-R-003)Endorobotics Co., Ltd.

官方來源

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