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FDA 510(k)

easyPPHTM Hemorrhoidal Stapler for Single Use

K号: K183477 · 2019-02-11

决定日期2019-02-11
产品代码GDW
咨询委员会SU
决定Substantially Equivalent

器械摘要

easyPPHTM Hemorrhoidal Stapler 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 2019-02-11 under 510(k) number K183477. 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 easyPPHTM Hemorrhoidal Stapler for Single Use?

easyPPHTM Hemorrhoidal Stapler for Single Use is a medical device that received FDA 510(k) clearance on 2019-02-11. The listed applicant is Ezisurg Medical Co., Ltd.. The 510(k) number is K183477.

When did easyPPHTM Hemorrhoidal Stapler for Single Use receive FDA 510(k) clearance?

easyPPHTM Hemorrhoidal Stapler for Single Use received FDA 510(k) clearance on 2019-02-11, under 510(k) number K183477.

Who is the listed applicant for easyPPHTM Hemorrhoidal Stapler for Single Use?

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

What is the FDA product code for easyPPHTM Hemorrhoidal Stapler for Single Use?

The FDA product code for easyPPHTM Hemorrhoidal Stapler for Single Use 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。

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 Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use CartridgesEzisurg 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, LLCK253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter ReloadsCovidien (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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