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FDA 510(k)

VitaVitro® 单腔卵母细胞采集针（ORNS-17G，ORNS-18G），VitaVitro® 双腔卵母细胞采集针（ORND-17G）

K号: K240523 · 2024-11-15

申请人Shenzhen Vitavitro Biotech Co., Ltd.
决定日期2024-11-15
产品代码MQE
咨询委员会OB 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Vitavitro Biotech Co., Ltd.. It received FDA 510(k) clearance on 2024-11-15 under 510(k) number K240523. The device is classified under product code MQE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)?

VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) is a medical device that received FDA 510(k) clearance on 2024-11-15. The listed applicant is Shenzhen Vitavitro Biotech Co., Ltd.. The 510(k) number is K240523.

When did VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) receive FDA 510(k) clearance?

VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) received FDA 510(k) clearance on 2024-11-15, under 510(k) number K240523.

Who is the listed applicant for VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)?

The FDA 510(k) record lists Shenzhen Vitavitro Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)?

The FDA product code for VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) is MQE.

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Shenzhen Vitavitro Biotech Co., Ltd.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。

K240307VitaVitro 胚胎移植导管（型号 ET-S、ET-SI、ET-A、ET-I、ET-IH）K212410VitaVitro 精子洗涤介质，VitaVitro 精子梯度介质K200408VitaVitro® 生育培养基，VitaVitro® 精子缓冲液，VitaVitro® 冲洗缓冲液K1910631步培养介质

相关器械（代码：MQE）

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。

K253121Giftlife单腔卵母细胞采集针，Giftlife双腔卵母细胞采集针Gimbo Medical Technology Shenzhen Co., Ltd.K232163Lotus单腔卵泡吸管针；Lotus双腔卵泡吸管针Zhejiang Horizon Medical Technology Co., Ltd.K190590Allwin卵母细胞采集针（ACE单腔卵母细胞采集针，OVUMPICK双腔卵母细胞采集针，ACE-FL单腔卵母细胞采集针带冲洗线，ACE-M手动单腔卵母细胞采集针）Allwin Medical Devices, Inc.K191291华莱士双腔卵母细胞采集系统CooperSurgical, Inc.K182959华莱士双腔卵母细胞采集系统CooperSurgical, Inc.K171625单腔卵圆囊吸引针Willian A. Cook Australia Pty, Ltd.

官方来源

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