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FDA 510(k)

Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload

K号: K161137 · 2016-07-20

申请人Cardica, Inc.
决定日期2016-07-20
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

Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload is the device name listed in this FDA 510(k) record. The listed applicant is Cardica, Inc.. It received FDA 510(k) clearance on 2016-07-20 under 510(k) number K161137. 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 Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload?

Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload is a medical device that received FDA 510(k) clearance on 2016-07-20. The listed applicant is Cardica, Inc.. The 510(k) number is K161137.

When did Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload receive FDA 510(k) clearance?

Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload received FDA 510(k) clearance on 2016-07-20, under 510(k) number K161137.

Who is the listed applicant for Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload?

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

What is the FDA product code for Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload?

The FDA product code for Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload 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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Cardica, Inc.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。

K151081MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge

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

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