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FDA 510(k)

120V Neptune S Rover (0711-001-000)；V2 4-端口歧管 (0750-400-000)；V2 标本收集歧管套装 (0750-200-000)；V2 标本收集托盘 (0750-210-000)

K号: K222552 · 2022-12-09

申请人Stryker Instruments
决定日期2022-12-09
产品代码JCX
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

120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000) is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments. It received FDA 510(k) clearance on 2022-12-09 under 510(k) number K222552. The device is classified under product code JCX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000)?

120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000) is a medical device that received FDA 510(k) clearance on 2022-12-09. The listed applicant is Stryker Instruments. The 510(k) number is K222552.

When did 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000) receive FDA 510(k) clearance?

120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000) received FDA 510(k) clearance on 2022-12-09, under 510(k) number K222552.

Who is the listed applicant for 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000)?

FDA 510(k)记录中列出Stryker Instruments为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000)?

The FDA product code for 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000) is JCX.

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 Instruments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。

K261959Neptune® 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）K261544Hydro 灌洗系统K253679Hydro 灌洗系统K252282SurgiCount+ SystemK251971RPS 主要全膝关节置换软件；RPS 控制台；RPS Saw One；RPS 电缆；RPS Saw 振动尖端卡式；RPS 控制台车附件；球头指针K250483PhotonBlade 3；PhotonBlade 3烟雾排放

查看所有 21 个设备 →

相关器械（代码：JCX）

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。

K250964便携式痰液吸引器（JMA D01）Jiangsu Jumao X-Care Medical Equipment Co., Ltd.K243638MV Flow 吸引泵（MVFLOWPMP01）MicroventionK251111CaryExcitus ASK243418Riptide™ 吸引泵；Riptide™ 收集罐与中间软管Micro Therapeutics, Inc. d/b/a ev3 NeurovascularK233428Easycess 吸引泵Guangzhou Easycess Medical Co.,LtdK182950Acare 吸痰器Acare Technology Co., Ltd.

官方来源

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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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