FDA 510(k)

Towako宫腔内胚胎移植套装

K号: K173431 · 2018-05-18

申请人William A. Cook Australia Pty. , Ltd.

决定日期2018-05-18

产品代码MQF

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决定实质等同

器械摘要

Towako Transmyometrial Embryo Transfer Set is the device name listed in this FDA 510(k) record. The listed applicant is William A. Cook Australia Pty. , Ltd.. It received FDA 510(k) clearance on 2018-05-18 under 510(k) number K173431. The device is classified under product code MQF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Towako Transmyometrial Embryo Transfer Set?

Towako Transmyometrial Embryo Transfer Set is a medical device that received FDA 510(k) clearance on 2018-05-18. The listed applicant is William A. Cook Australia Pty. , Ltd.. The 510(k) number is K173431.

When did Towako Transmyometrial Embryo Transfer Set receive FDA 510(k) clearance?

Towako Transmyometrial Embryo Transfer Set received FDA 510(k) clearance on 2018-05-18, under 510(k) number K173431.

Who is the listed applicant for Towako Transmyometrial Embryo Transfer Set?

The FDA 510(k) record lists William A. Cook Australia Pty. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Towako Transmyometrial Embryo Transfer Set?

The FDA product code for Towako Transmyometrial Embryo Transfer Set is MQF.

列明William A. Cook Australia Pty. , 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。

K171611双腔卵泡吸取针 K160753COOK 真空泵 K170257Sydney IVF 培养油 K153478Sydney IVF 精子缓冲液 K152717Sydney IVF 胚胎冷冻保存试剂盒，Sydney IVF 胚胎解冻试剂盒 K160814Sydney IVF 精子冷冻保存缓冲液

查看所有 9 个设备 →

相关器械（代码：MQF）

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。

K253354Minvitro 胚胎移植导管 (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)Guangzhou Hehong Biotech Co., Ltd.K243373Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511)Vitrolife Sweden AB K240307VitaVitro 胚胎移植导管（型号 ET-S、ET-SI、ET-A、ET-I、ET-IH）Shenzhen Vitavitro Biotech Co., Ltd.K231730FemaSeed 宫腔内人工授精Femasys, Inc.K220010百合单次使用无菌胚胎移植导管Shanghai Horizon Medical Technology Co., Ltd.K200248Allwin胚胎移植导管（ETC），Allwin ETC型芯和软塞Allwin Medical Devices, Inc.

官方来源

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