FDA 510(k)

侵入式封合器（MIS）Flex，侵入式封合器（MIS）Flex Mini

K 號：K170381 · 2017-09-07

決定日期2017-09-07

產品代碼GEI

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Advanced Energy. It received FDA 510(k) clearance on 2017-09-07 under 510(k) number K170381. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini?

Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini is a medical device that received FDA 510(k) clearance on 2017-09-07. The listed applicant is Medtronic Advanced Energy. The 510(k) number is K170381.

When did Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini receive FDA 510(k) clearance?

Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini received FDA 510(k) clearance on 2017-09-07, under 510(k) number K170381.

Who is the listed applicant for Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini?

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

What is the FDA product code for Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini?

The FDA product code for Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini is GEI.

其他以 Medtronic Advanced Energy 為申請人之記錄

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