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FDA 510(k)

多功能手术解剖器（电外科笔）；多功能手术解剖器（一次性电极）

K号: K260466 · 2026-04-07

申请人Zhejiang shuyou Surgical Instrument Co., Ltd.
决定日期2026-04-07
产品代码GEI
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode) is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang shuyou Surgical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2026-04-07 under 510(k) number K260466. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode)?

Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode) is a medical device that received FDA 510(k) clearance on 2026-04-07. The listed applicant is Zhejiang shuyou Surgical Instrument Co., Ltd.. The 510(k) number is K260466.

When did Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode) receive FDA 510(k) clearance?

Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode) received FDA 510(k) clearance on 2026-04-07, under 510(k) number K260466.

Who is the listed applicant for Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode)?

The FDA 510(k) record lists Zhejiang shuyou Surgical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode)?

The FDA product code for Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode) is GEI.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：GEI）

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）Ethicon Endo-Surgery, LLCK261959Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，70mm刀片，推钮开关（0703-046-100）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，推钮开关，大批量非无菌（0703-046-102）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，70mm刀片，旋转开关（0703-047-100）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，旋转开关，大批量非无菌（0703-047-102）Stryker InstrumentsK261070LigaSure™ RAS 马里兰州颚部血管封合/分割器，纳米涂层Covidien, LLCK254185Potenza PrimeJeisys Medical IncorporatedK262364艾利安谜团射频设备Ellian CorpK253859Scarlet Pro（Scarlet Pro）VIOL Co., Ltd.

官方来源

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