AEON™ ˿
K号: K251482 · 2025-07-11
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决定日期2025-07-11
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
AEON™ Endoscopic Powered Stapler is the device name listed in this FDA 510(k) record. The listed applicant is Lexington Medical, Inc.. It received FDA 510(k) clearance on 2025-07-11 under 510(k) number K251482. 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 AEON™ Endoscopic Powered Stapler?
AEON™ Endoscopic Powered Stapler is a medical device that received FDA 510(k) clearance on 2025-07-11. The listed applicant is Lexington Medical, Inc.. The 510(k) number is K251482.
When did AEON™ Endoscopic Powered Stapler receive FDA 510(k) clearance?
AEON™ Endoscopic Powered Stapler received FDA 510(k) clearance on 2025-07-11, under 510(k) number K251482.
Who is the listed applicant for AEON™ Endoscopic Powered Stapler?
The FDA 510(k) record lists Lexington Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AEON™ Endoscopic Powered Stapler?
The FDA product code for AEON™ Endoscopic Powered Stapler 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Lexington Medical, Inc.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：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, LLCK243596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, LLCK234039AEON 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.K231934GIA™ 钉合器带三钉™ 技术Covidien
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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