FDA 510(k)

CORE E3吸引/冲洗器

K号: K202303 · 2021-02-19

决定日期2021-02-19

产品代码GCJ

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决定实质等同

器械摘要

CORE E3 Suction/irrigator is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Corporation. It received FDA 510(k) clearance on 2021-02-19 under 510(k) number K202303. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CORE E3 Suction/irrigator?

CORE E3 Suction/irrigator is a medical device that received FDA 510(k) clearance on 2021-02-19. The listed applicant is Conmed Corporation. The 510(k) number is K202303.

When did CORE E3 Suction/irrigator receive FDA 510(k) clearance?

CORE E3 Suction/irrigator received FDA 510(k) clearance on 2021-02-19, under 510(k) number K202303.

Who is the listed applicant for CORE E3 Suction/irrigator?

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

What is the FDA product code for CORE E3 Suction/irrigator?

The FDA product code for CORE E3 Suction/irrigator is GCJ.

列明Conmed Corporation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。

K261363Y-Knotless™ 无结锚 K253763Y-Knotless™ 无结锚 K252946BioBrace® 髋关节外韧带增强套件 K251530CONMED Argo Knotless® Anchor K250395BioBrace® RC 递送系统 K244025Argo 无结 GENESYS 锚

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相关器械（代码：GCJ）

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。

K262397CuratOR EX2742Eizo Corporation K260884UNIDRIVE选择系统Karl Storz SE & CO. KG K260972OEV-271MUH 液晶显示器；OEV-321MUH 液晶显示器；OEV-431MUH 液晶显示器Sony Corporation K261139VereSee（VER150、VER200、VER151、VER201、VER200C和VER-100-103）Freyja Healthcare, LLC K253541EZ-Close™（EZ Close 端口部位闭合装置，EZ Close MAX 端口部位闭合装置，EZ Close II 端口部位闭合装置）Medical Impact K261614LED液晶显示器（OEV-271H）Lg Electronics.Inc

官方来源

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