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FDA 510(k)

ISIS 头箱，ISIS 神经刺激器，ISIS Xpert Plus，ISIS Xpert，ISIS Xpress

K号: K263010 · 2026-09-24

申请人inomed Medizintechnik GmbH
决定日期2026-09-24
产品代码GWF
咨询委员会NE
决定Substantially Equivalent

器械摘要

ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress is the device name listed in this FDA 510(k) record. The listed applicant is inomed Medizintechnik GmbH. It received FDA 510(k) clearance on 2026-09-24 under 510(k) number K263010. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress?

ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress is a medical device that received FDA 510(k) clearance on 2026-09-24. The listed applicant is inomed Medizintechnik GmbH. The 510(k) number is K263010.

When did ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress receive FDA 510(k) clearance?

ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress received FDA 510(k) clearance on 2026-09-24, under 510(k) number K263010.

Who is the listed applicant for ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress?

The FDA 510(k) record lists inomed Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress?

The FDA product code for ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress is GWF.

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。

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (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

列明inomed Medizintechnik GmbH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。

K242852ALM 管内径 6.0, 外径 8.2 (520843), ALM 管内径 7.0, 外径 9.7 (520845), ALM 管内径 7.5, 外径 10.3 (520846), ALM 管内径 8.0, 外径 11.0 (520847)K233292ISIS 头箱，ISIS 神经刺激器，ISIS Xpert Plus，ISIS Xpert，ISIS XpressK223254C2 XploreK212164Mapping Suction ProbeK212166ISIS 头箱，ISIS 神经刺激器，ISIS Xpert Plus，ISIS Xpert，ISIS XpressK152505C2 神经监测系统

查看所有 7 个设备 →

相关器械（代码：GWF）

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。

K253301BraiN20® (BraiN20)Time IS Brain, S.L.K252842SafeOp 3：Neural Informatix SystemAlphatec Spine, Inc.K243982Nicolet EDXNatus Neurology IncorporatedK243495Natus Ultrapro S100 (982A0594)Natus Neurology IncorporatedK242345Delphi StimulatorQuantalx NeuroscienceK234092SafeOp 3：Neural Informatix SysteemAlphatec Spine, Inc.

官方来源

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