FDA 510(k)

EEA®圆形吻合器带三钉®技术和OrVil®经口圆形吻合器底座

K号: K232126 · 2023-08-16

决定日期2023-08-16

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

EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2023-08-16 under 510(k) number K232126. 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 EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil?

EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil is a medical device that received FDA 510(k) clearance on 2023-08-16. The listed applicant is Covidien. The 510(k) number is K232126.

When did EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil receive FDA 510(k) clearance?

EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil received FDA 510(k) clearance on 2023-08-16, under 510(k) number K232126.

Who is the listed applicant for EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil?

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 EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil?

The FDA product code for EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil is GAG.

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)K231491TA® 钳和带 DST 系列技术加载单元

查看所有 61 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。

K253527Tri-Staple™ 2.0 黑色圆形加厚装填 21mm 超厚（SIGCIR21XT）；Tri-Staple™ 2.0 黑色圆形加厚装填 25mm 超厚（SIGCIR25XT）Covidien, LLC K251482AEON™ ˿Lexington Medical, Inc.K243596达芬奇SP SureForm 45吻合器及重装（SP1098）Intuitive Surgical, Inc.K240881Signia™ 圆形适配器（标准长度）（SIGCIRSTND）；Signia™ 圆形适配器 XL 长度（SIGCIRXL）Covidien (Part of Medtronic)K241629ECHELON 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）Ethicon Endo-Surgery, LLC K234039AEON 内窥镜动力钉合器（短/AEPH060）；AEON 内窥镜动力钉合器（中/AEPH160）；AEON 内窥镜动力钉合器（长/AEPH260）Lexington Medical, Inc.

官方来源

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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。