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FDA 510(k)

LithoVue Elite 单次使用数字柔性输尿管镜 - 标准带压力监测（M0067940000）；LithoVue Elite 单次使用数字柔性输尿管镜 - 反向带压力监测（M0067940500）

K号: K252703 · 2025-09-24

申请人Boston Scientific Corporation
决定日期2025-09-24
产品代码FGB
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

LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500) is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2025-09-24 under 510(k) number K252703. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500)?

LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500) is a medical device that received FDA 510(k) clearance on 2025-09-24. The listed applicant is Boston Scientific Corporation. The 510(k) number is K252703.

When did LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500) receive FDA 510(k) clearance?

LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500) received FDA 510(k) clearance on 2025-09-24, under 510(k) number K252703.

Who is the listed applicant for LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500)?

FDA 510(k)记录显示波士顿科学公司为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500)?

The FDA product code for LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500) is FGB.

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Boston Scientific 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。

K262151SpaceOAR Flex™ 系统K261153LithoVue Elite 数字柔性输尿管镜系统K261915Navigator™ Flex 肾盂输尿管通路鞘套装K262165FARADRIVE™ 导向鞘（M004PF21M402）K262462TheraSphere 360® Y-90管理平台K261488OBSIDIO 可变形栓塞

查看所有 167 个设备 →

相关器械（代码：FGB）

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。

K261447CVAC® 吸引系统Calyxo, Inc.K262488一次性使用视频软性输尿管肾镜（RP-U-C06R9，RP-U-C06R3，RP-U-C06S9，RP-U-C06S3）Guangzhou Red Pine Medical Instrument Co., Ltd.K261153LithoVue Elite 数字柔性输尿管镜系统Boston Scientific CorporationK262552一次性使用柔性输尿管镜（一次性使用柔性输尿管镜：SUV-5C-B）Scivita Medical Technology Co., Ltd.K253505Zamenix™ PRoen Surgical, Inc.K260516BubbleView 单次使用数字柔性膀胱镜（C38-CS，C38-CRS，C50-C，C50-CR，C50-CB，C50-CBR）MacroLux Medical Technology Co., Ltd.

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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