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FDA 510(k)

Daylily Single Use Sterile Embryo Transfer Catheter

K-Number: K220010 · 2022-12-16

ApplicantShanghai Horizon Medical Technology Co., Ltd.
Decision Date2022-12-16
Product CodeMQF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07641491Silver-Impregnated Dressings for Catheter Exit-Site and Tunnel Infections in Peritoneal Dialysis PatientsNOT_YET_RECRUITINGNCT06016582Use of Virtual Reality Medical Hypnosis for Anxiolytic Purposes During Frozen Embryo TransferCOMPLETEDNCT07396181Standardization of Variable Conditions of Embryo Transfer Into the Uterine Cavity in the Procedure of Medically Assisted Procreation in HumansRECRUITINGNCT06744049Transfer Direct System as a New Method for Embryo TransferRECRUITING

Related Devices (Code: MQF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 ABK240307VitaVitro 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

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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