FDA 510(k)

微创密封器（MIS）Flex，微创密封器（MIS）Flex Mini

K号: K170381 · 2017-09-07

决定日期2017-09-07

产品代码GEI

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决定实质等同

器械摘要

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.

常见问题

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.

列明Medtronic Advanced Energy为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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相关器械（代码：GEI）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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