一次性射频消融电极
K号: K253907 · 2026-04-16
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决定日期2026-04-16
产品代码GXI
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
Disposable Radiofrequency Cannula is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2026-04-16 under 510(k) number K253907. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Disposable Radiofrequency Cannula?
Disposable Radiofrequency Cannula is a medical device that received FDA 510(k) clearance on 2026-04-16. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K253907.
When did Disposable Radiofrequency Cannula receive FDA 510(k) clearance?
Disposable Radiofrequency Cannula received FDA 510(k) clearance on 2026-04-16, under 510(k) number K253907.
Who is the listed applicant for Disposable Radiofrequency Cannula?
The FDA 510(k) record lists ABBOTT MEDICAL as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Disposable Radiofrequency Cannula?
The FDA product code for Disposable Radiofrequency Cannula is GXI.
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ABBOTT MEDICAL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。
K261729EnSite™ X EP系统K262006EnSite™ X EP系统K261631Amplatzer TorqVue 交换系统K253459OPTIS 移动 Next 成像系统 (1014932)；OPTIS 集成 Next 成像系统 (1014933)；Ultreon 3.0 软件升级套件 (ULTR300001)K260212EnSite™ X EP系统K260499Amplatzer™ Trevisio™ 血管内输送系统；9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80
相关器械（代码：GXI）
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。
K251802STAR RF Ablation SystemMerit Medical Systems, Inc.K251243OneRF 三叉神经射频探针Neuroone Medical Technologies Corp.K242841一次性射频电极（RFDE-5/RFDE-10/RFDE-15/RFDE-20）ABBOTT MEDICALK250213OptaBlate BVN 骨内神经消融系统（10mm探头单套件）；OptaBlate BVN 骨内神经消融系统（10mm探头双套件）Stryker InstrumentsK241367使用多叉电极与传统电极进行腰椎椎间盘突出症射频消融的比较Shanghai Samedical & Plastic Instruments Co., Ltd.K222281Intracept 骨内神经消融系统Relievant Medsystems, Inc.
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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