FDA 510(k)

PlasmaBlade T

K号: K170610 · 2017-04-13

决定日期2017-04-13

产品代码GEI

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决定实质等同

器械摘要

PlasmaBlade T 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 2017-04-13 under 510(k) number K170610. 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 PlasmaBlade T?

PlasmaBlade T is a medical device that received FDA 510(k) clearance on 2017-04-13. The listed applicant is Medtronic Advanced Energy. The 510(k) number is K170610.

When did PlasmaBlade T receive FDA 510(k) clearance?

PlasmaBlade T received FDA 510(k) clearance on 2017-04-13, under 510(k) number K170610.

Who is the listed applicant for PlasmaBlade T?

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 PlasmaBlade T?

The FDA product code for PlasmaBlade T 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。

K183129Medtronic 全髋关节置换系统 K181257PlasmaBlade X 3.0S，PlasmaBlade X 4.0 K170381微创密封器（MIS）Flex，微创密封器（MIS）Flex Mini K170296CoreCath 2.7S K152703PlasmaBlade TnA扁桃体和腺样体切除装置

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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