FDA 510(k)

SAGE 玻璃化试剂盒（ART-8025和ART-8026）/ SAGE 玻璃化加热试剂盒（ART-8030和ART-8031）

K号: K173731 · 2018-03-02

决定日期2018-03-02

产品代码MQL

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决定实质等同

器械摘要

SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031) is the device name listed in this FDA 510(k) record. The listed applicant is CooperSurgical, Inc.. It received FDA 510(k) clearance on 2018-03-02 under 510(k) number K173731. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031)?

SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031) is a medical device that received FDA 510(k) clearance on 2018-03-02. The listed applicant is CooperSurgical, Inc.. The 510(k) number is K173731.

When did SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031) receive FDA 510(k) clearance?

SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031) received FDA 510(k) clearance on 2018-03-02, under 510(k) number K173731.

Who is the listed applicant for SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031)?

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 SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031)?

The FDA product code for SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031) is MQL.

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：MQL）

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。

K254261玻璃化冷冻试剂盒和解冻试剂盒（CS-IVF-FK；CS-IVF-TK）CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.K260248超快速升温Kitazato Corporation K252672CaseBio® Culture w/HSA (CMH5)；CaseBio® Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine Scientific K251637Dewin 生殖培养基（Dewin 精子缓冲液[含HSA和不含HSA]; Dewin 卵泡冲洗液，Dewin 一步法培养基[含HSA和不含HSA]）Donnevie Medical Technology (Shanghai) Co. , Ltd.K251305超快速玻璃化；超快速温控Kitazato Corporation

官方来源

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