FDA 510(k)

华莱士双腔卵母细胞采集系统

K号: K182959 · 2019-05-10

决定日期2019-05-10

产品代码MQE

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决定实质等同

器械摘要

Wallace Dual Lumen Oocyte Recovery System is the device name listed in this FDA 510(k) record. The listed applicant is CooperSurgical, Inc.. It received FDA 510(k) clearance on 2019-05-10 under 510(k) number K182959. 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 Wallace Dual Lumen Oocyte Recovery System?

Wallace Dual Lumen Oocyte Recovery System is a medical device that received FDA 510(k) clearance on 2019-05-10. The listed applicant is CooperSurgical, Inc.. The 510(k) number is K182959.

When did Wallace Dual Lumen Oocyte Recovery System receive FDA 510(k) clearance?

Wallace Dual Lumen Oocyte Recovery System received FDA 510(k) clearance on 2019-05-10, under 510(k) number K182959.

Who is the listed applicant for Wallace Dual Lumen Oocyte Recovery System?

FDA 510(k)记录中列出CooperSurgical, Inc.为申请人。这本身并不足以确立设备制造商。

What is the FDA product code for Wallace Dual Lumen Oocyte Recovery System?

The FDA product code for Wallace Dual Lumen Oocyte Recovery System is MQE.

列明CooperSurgical, Inc.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。

K261083华莱士® 吸引泵（WAPV1）；华莱士® 泵过滤器连接器（WFC）；华莱士® 真空连接套件（WVCK）K243799复杂腹裂胎儿修复：一项安全性和可行性试验 K250438CooperSurgical Milex® 子宫托 K223064ALLY II子宫定位系统™（UPS）K201086Advincula Delineator 宫腔操纵器 K200038Endosee System

查看所有 16 个设备 →

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。

官方来源

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