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FDA 510(k)

ETHICON 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)

K号: K250835 · 2025-05-14

决定日期2025-05-14
产品代码GDW
咨询委员会SU
决定Substantially Equivalent

器械摘要

ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T) is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Endo-Surgery, LLC. It received FDA 510(k) clearance on 2025-05-14 under 510(k) number K250835. 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 ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T)?

ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T) is a medical device that received FDA 510(k) clearance on 2025-05-14. The listed applicant is Ethicon Endo-Surgery, LLC. The 510(k) number is K250835.

When did ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T) receive FDA 510(k) clearance?

ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T) received FDA 510(k) clearance on 2025-05-14, under 510(k) number K250835.

Who is the listed applicant for ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T)?

The FDA 510(k) record lists Ethicon Endo-Surgery, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T)?

The FDA product code for ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T) 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Ethicon Endo-Surgery, LLC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。

K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)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)K252906ECHELON ENDOPATH 订书线加固(ECH60R)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)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)K241630ECHELON 4000 60mm 紧凑型订书机(EC3D60C);ECHELON 4000 60mm 标准订书机(EC3D60S);ECHELON 4000 60mm 长订书机(EC3D60L);ECHELON 3D 60mm 白色重载(ER60W);ECHELON 3D 60mm 蓝色重载(ER60B);ECHELON 3D 60mm 绿色重载(ER60G);ECHELON 3D 60mm 黑色重载(ER60T)

查看所有 35 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 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, 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, LLCK241630ECHELON 4000 60mm 紧凑型订书机(EC3D60C);ECHELON 4000 60mm 标准订书机(EC3D60S);ECHELON 4000 60mm 长订书机(EC3D60L);ECHELON 3D 60mm 白色重载(ER60W);ECHELON 3D 60mm 蓝色重载(ER60B);ECHELON 3D 60mm 绿色重载(ER60G);ECHELON 3D 60mm 黑色重载(ER60T)Ethicon Endo-Surgery, LLC

官方来源

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