FDA 510(k)

easyEndo™ 线性切割夹持器和一次性使用加载单元，easyEndo™ 通用线性切割夹持器和一次性使用加载单元

K号: K172960 · 2017-12-21

决定日期2017-12-21

产品代码GDW

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决定实质等同

器械摘要

easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Ezisurg Medical Co., Ltd.. It received FDA 510(k) clearance on 2017-12-21 under 510(k) number K172960. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use?

easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use is a medical device that received FDA 510(k) clearance on 2017-12-21. The listed applicant is Ezisurg Medical Co., Ltd.. The 510(k) number is K172960.

When did easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use receive FDA 510(k) clearance?

easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use received FDA 510(k) clearance on 2017-12-21, under 510(k) number K172960.

Who is the listed applicant for easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use?

FDA 510(k)记录将Ezisurg Medical Co., Ltd.列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use?

The FDA product code for easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use is GDW.

列明Ezisurg Medical Co., Ltd.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。

K254291easyEndo™ E-Lite 单次使用电动内窥镜吻合器；easyEndo™ E-Lite 单次使用带弯曲尖端的电动内窥镜吻合器；easyEndo™ E-Lite 单次使用弹匣 K210909easyEndo Lite 线性切割钉合器及单次使用装载单元 K183477easyPPHTM 单次使用痔疮吻合器 K181657easyLCTM 线性切割器夹持器和单次使用加载单元；easyCSTM 单次使用圆形夹持器

相关器械（代码：GDW）

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。

K254291easyEndo™ E-Lite 单次使用电动内窥镜吻合器；easyEndo™ E-Lite 单次使用带弯曲尖端的电动内窥镜吻合器；easyEndo™ E-Lite 单次使用弹匣Ezisurg Medical Co., Ltd.K260196ETHICON™ 圆形夹持器（CDH21mm）；ETHICON™ 圆形夹持器（CDH25mm）；ETHICON™ 圆形夹持器（CDH29mm）；ETHICON™ 圆形夹持器（CDH33mm）；ETHICON™ 圆形夹持器 - XL 密封（ECS21mm）；ETHICON™ 圆形夹持器 - XL 密封（ECS25mm）；ETHICON™ 圆形夹持器 - XL 密封（ECS29mm）；ETHICON™ 圆形夹持器 - XL 密封（ECS33mm）Ethicon Endo-Surgery, LLC K253657三钉2.0™重装；Endo GIA™重装配备三钉™技术；Endo GIA™灰色活动重装；Signia™小直径重装Covidien (Part of Medtronic)K252739ETHICON™ 4000 45mm 紧凑夹持器（EC3DT45C）；ETHICON™ 4000 45mm 标准夹持器（EC3DT45S）；ETHICON™ 4000 45mm 长夹持器（EC3DT45L）；ETHICON™ 3D 45mm 白色重载（ER45W）；ETHICON™ 3D 45mm 蓝色重载（ER45B）；ETHICON™ 3D 45mm 绿色重载（ER45G）；ETHICON™ 3D 45mm 黑色重载（ER45T）Ethicon Endo-Surgery, LLC K250835ETHICON 4000 60mm 紧凑夹持器（EC3D60C）；ETHICON 4000 60mm 标准夹持器（EC3D60S）；ETHICON 4000 60mm 长夹持器（EC3D60L）；ETHICON 3D 60mm 白色重载（ER60W）；ETHICON 3D 60mm 蓝色重载（ER60B）；ETHICON 3D 60mm 绿色重载（ER60G）；ETHICON 3D 60mm 黑色重载（ER60T）Ethicon Endo-Surgery, LLC K243276ECHELON LINEAR® 钳子 30mm 钳子 (GTX30)；ECHELON LINEAR® 钳子 60mm 钳子 (GTX60)；ECHELON LINEAR® 钳子 90mm 钳子 (GTX90)；ECHELON LINEAR® 钳子 3D 30mm 蓝色重装 (GTXR30B)；ECHELON LINEAR® 钳子 3D 30mm 绿色重装 (GTXR30G)；ECHELON LINEAR® 钳子 3D 60mm 蓝色重装 (GTXR60B)；ECHELON LINEAR® 钳子 3D 60mm 绿色重装 (GTXR60G)；ECHELON LINEAR® 钳子 3D 90mm 蓝色重装 (GTXR90B)；ECHELON LINEAR® 钳子 3D 90mm 绿色重装 (GTXR90G)Ethicon Endo-Surgery, LLC

官方来源

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