FDA 510(k)

Daylily Single Use Sterile Embryo Transfer Catheter

Numéro K : K220010 · 2022-12-16

DemandeurShanghai Horizon Medical Technology Co., Ltd.

Date de décision2022-12-16

Code produitMQF

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

Daylily Single Use Sterile Embryo Transfer Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Horizon Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-12-16 under 510(k) number K220010. The device is classified under product code MQF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Daylily Single Use Sterile Embryo Transfer Catheter?

Daylily Single Use Sterile Embryo Transfer Catheter is a medical device that received FDA 510(k) clearance on 2022-12-16. The listed applicant is Shanghai Horizon Medical Technology Co., Ltd.. The 510(k) number is K220010.

When did Daylily Single Use Sterile Embryo Transfer Catheter receive FDA 510(k) clearance?

Daylily Single Use Sterile Embryo Transfer Catheter received FDA 510(k) clearance on 2022-12-16, under 510(k) number K220010.

Who is the listed applicant for Daylily Single Use Sterile Embryo Transfer Catheter?

The FDA 510(k) record lists Shanghai Horizon Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Daylily Single Use Sterile Embryo Transfer Catheter?

The FDA product code for Daylily Single Use Sterile Embryo Transfer Catheter is MQF.

Essais cliniques associés

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Dispositifs connexes (Code : MQF)

K253354Minvitro Embryo Transfer Catheters (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 Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)Shenzhen Vitavitro Biotech Co., Ltd.K231730FemaSeed Intratubal InseminationFemasys, Inc.K200248Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft ObturatorsAllwin Medical Devices, Inc.K192540Kitazato ET CathetersKitazato Corporation

Source officielle

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