免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据，仅供一般参考，不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

带有设备和语音控制的连接手术室中心，SDC4K信息管理系统

K号: K232157 · 2023-08-18

申请人Stryker Corporation
决定日期2023-08-18
产品代码GCJ
咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同

器械摘要

Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation. It received FDA 510(k) clearance on 2023-08-18 under 510(k) number K232157. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control?

Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control is a medical device that received FDA 510(k) clearance on 2023-08-18. The listed applicant is Stryker Corporation. The 510(k) number is K232157.

When did Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control receive FDA 510(k) clearance?

Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control received FDA 510(k) clearance on 2023-08-18, under 510(k) number K232157.

Who is the listed applicant for Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control?

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

What is the FDA product code for Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control?

The FDA product code for Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control is GCJ.

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

列明Stryker Corporation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。

K212194Stryker Q引导系统及颅骨引导软件，CranialMask追踪器和显微镜追踪器，被动光学导航仪器，Mayfield底座带活动臂，导航活检针，电磁导航仪器，精确靶向系统K223770Sonopet 1Q 3 7cm 1Q LargeK221728Aviator® 前颈椎板（ACP）系统，LITe® 板系统，DynaTran™ 前颈椎板（ACP）系统，Reflex™ 混合ACP系统，UniVise™ 椎板固定板系统K221074OptaBlate RF 发生器，OptaBlate 探头，OptaBlate 微注射注射装置K221098Scopis ENT软件，Scopis ENT软件带TGS，Scopis规划软件，电磁导航单元K213824Sonopet iQ 超声波吸引器系统

查看所有 42 个设备 →

相关器械（代码：GCJ）

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。

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE选择系统Karl Storz SE & CO. KGK260972OEV-271MUH 液晶显示器；OEV-321MUH 液晶显示器；OEV-431MUH 液晶显示器Sony CorporationK261139VereSee（VER150、VER200、VER151、VER201、VER200C和VER-100-103）Freyja Healthcare, LLCK253541EZ-Close™（EZ Close 端口部位闭合装置，EZ Close MAX 端口部位闭合装置，EZ Close II 端口部位闭合装置）Medical ImpactK261614LED液晶显示器（OEV-271H）Lg Electronics.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。

↑