免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据，仅供一般参考，不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

一次性内镜吻合器和重载单元，一次性痔疮切割吻合器，一次性线性切割吻合器，一次性圆形吻合器

K号: K211811 · 2022-03-03

申请人Wuxi Beien Surgery Device Co., Ltd.
决定日期2022-03-03
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 Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers is the device name listed in this FDA 510(k) record. The listed applicant is Wuxi Beien Surgery Device Co., Ltd.. It received FDA 510(k) clearance on 2022-03-03 under 510(k) number K211811. 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 Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers?

Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers is a medical device that received FDA 510(k) clearance on 2022-03-03. The listed applicant is Wuxi Beien Surgery Device Co., Ltd.. The 510(k) number is K211811.

When did Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers receive FDA 510(k) clearance?

Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers received FDA 510(k) clearance on 2022-03-03, under 510(k) number K211811.

Who is the listed applicant for Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers?

The FDA 510(k) record lists Wuxi Beien Surgery Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers?

The FDA product code for Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers 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

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

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

↑