FDA 510(k)

GIA 自动缝合钉合器带DST系列技术

K号: K221013 · 2022-05-05

决定日期2022-05-05

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

GIA Auto Suture Stapler with DST Series Technology is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2022-05-05 under 510(k) number K221013. 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 GIA Auto Suture Stapler with DST Series Technology?

GIA Auto Suture Stapler with DST Series Technology is a medical device that received FDA 510(k) clearance on 2022-05-05. The listed applicant is Covidien. The 510(k) number is K221013.

When did GIA Auto Suture Stapler with DST Series Technology receive FDA 510(k) clearance?

GIA Auto Suture Stapler with DST Series Technology received FDA 510(k) clearance on 2022-05-05, under 510(k) number K221013.

Who is the listed applicant for GIA Auto Suture Stapler with DST Series Technology?

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

What is the FDA product code for GIA Auto Suture Stapler with DST Series Technology?

The FDA product code for GIA Auto Suture Stapler with DST Series Technology is GDW.

列明Covidien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。

K241486Sofsilk™涂层编织丝绸缝合线 K240077Mon-a-Therm®通用温度探头400TM（90050, 90044）K231934GIA™ 钉合器带三钉™ 技术 K231240MaxTack® 电动固定装置 K223130Shiley™ 儿童口腔/鼻腔气管导管带 TaperGuard™ Cuff，非DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)K232126EEA®圆形吻合器带三钉®技术和OrVil®经口圆形吻合器底座

查看所有 61 个设备 →

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

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。