FDA 510(k)

FemaSeed 宫腔内人工授精

K号: K231730 · 2023-09-22

决定日期2023-09-22

产品代码MQF

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决定实质等同

器械摘要

FemaSeed Intratubal Insemination is the device name listed in this FDA 510(k) record. The listed applicant is Femasys, Inc.. It received FDA 510(k) clearance on 2023-09-22 under 510(k) number K231730. 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 FemaSeed Intratubal Insemination?

FemaSeed Intratubal Insemination is a medical device that received FDA 510(k) clearance on 2023-09-22. The listed applicant is Femasys, Inc.. The 510(k) number is K231730.

When did FemaSeed Intratubal Insemination receive FDA 510(k) clearance?

FemaSeed Intratubal Insemination received FDA 510(k) clearance on 2023-09-22, under 510(k) number K231730.

Who is the listed applicant for FemaSeed Intratubal Insemination?

The FDA 510(k) record lists Femasys, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FemaSeed Intratubal Insemination?

The FDA product code for FemaSeed Intratubal Insemination is MQF.

列明Femasys, 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。

K253403FemVue® 控制盐水-空气装置 (FSA-300)K242002FemVue MINI 盐水-空气装置 K241693FemChec 控制盐水-空气装置 (FCD-250)

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.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.K192540Kitazato ET 管套Kitazato Corporation

官方来源

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