FDA 510(k)

ABC D-FLEX PROBE

K号: K151229 · 2016-06-02

决定日期2016-06-02

产品代码GEI

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决定实质等同

器械摘要

ABC D-FLEX PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Corporation. It received FDA 510(k) clearance on 2016-06-02 under 510(k) number K151229. 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 ABC D-FLEX PROBE?

ABC D-FLEX PROBE is a medical device that received FDA 510(k) clearance on 2016-06-02. The listed applicant is Conmed Corporation. The 510(k) number is K151229.

When did ABC D-FLEX PROBE receive FDA 510(k) clearance?

ABC D-FLEX PROBE received FDA 510(k) clearance on 2016-06-02, under 510(k) number K151229.

Who is the listed applicant for ABC D-FLEX PROBE?

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 ABC D-FLEX PROBE?

The FDA product code for ABC D-FLEX PROBE is GEI.

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：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。

K254196HARMONIC 1100 剪刀（HAR1120）；HARMONIC 1100 剪刀（HAR1136）Ethicon Endo-Surgery, LLC K261959Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，70mm刀片，推钮开关（0703-046-100）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，推钮开关，大批量非无菌（0703-046-102）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，70mm刀片，旋转开关（0703-047-100）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，旋转开关，大批量非无菌（0703-047-102）Stryker Instruments K261070LigaSure™ RAS 马里兰州颚部血管封合/分割器，纳米涂层Covidien, LLC K254185Potenza PrimeJeisys Medical Incorporated K262364艾利安谜团射频设备Ellian Corp K253859Scarlet Pro（Scarlet Pro）VIOL Co., Ltd.

官方来源

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