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FDA 510(k)

ECHELON 3000 45mm 紧凑型订书机(ECH45C);Echelon 3000 45mm 标准订书机(ECH45S);Echelon 3000 45mm 长订书机(ECH45L);Echelon 3000 60mm 紧凑型订书机(ECH60C);Echelon 3000 60mm 标准订书机(ECH60S);Echelon 3000 60mm 长订书机(ECH60L)

K号: K241629 · 2024-07-03

决定日期2024-07-03
产品代码GAG
咨询委员会医疗设备监管文本翻译如下: HO 请注意,由于您没有提供具体的医疗设备监管文本内容,以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同

器械摘要

ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L) 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 2024-07-03 under 510(k) number K241629. The device is classified under product code GAG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)?

ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L) is a medical device that received FDA 510(k) clearance on 2024-07-03. The listed applicant is Ethicon Endo-Surgery, LLC. The 510(k) number is K241629.

When did ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L) receive FDA 510(k) clearance?

ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L) received FDA 510(k) clearance on 2024-07-03, under 510(k) number K241629.

Who is the listed applicant for ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)?

FDA 510(k)记录中列出Ethicon Endo-Surgery, LLC为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)?

The FDA product code for ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L) is GAG.

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 剪刀(HAR1120);HARMONIC 1100 剪刀(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)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)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)

查看所有 35 个设备 →

相关器械(代码:GAG)

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。

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。

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