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FDA 510(k)

一次性痔疮圆形吻合器,一次性圆形吻合器,一次性线性吻合器,一次性内镜线性切割吻合器及弹匣,一次性线性切割吻合器及吻合器弹匣

K号: K161905 · 2016-11-17

决定日期2016-11-17
产品代码GDW
咨询委员会SU 请注意,您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd. It received FDA 510(k) clearance on 2016-11-17 under 510(k) number K161905. 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 Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge?

Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge is a medical device that received FDA 510(k) clearance on 2016-11-17. The listed applicant is Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd. The 510(k) number is K161905.

When did Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge receive FDA 510(k) clearance?

Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge received FDA 510(k) clearance on 2016-11-17, under 510(k) number K161905.

Who is the listed applicant for Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge?

The FDA 510(k) record lists Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge?

The FDA product code for Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge is GDW.

相关临床试验

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。

列明Changzhou Xin Neng Yuan Medical Stapler 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。

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, LLCK253657三钉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, LLCK250835ETHICON 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, LLCK243276ECHELON 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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