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FDA 510(k)

Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter

K-Number: K173686 · 2018-04-11

ApplicantCook Incorporated
Decision Date2018-04-11
Product CodeMQF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2018-04-11 under 510(k) number K173686. 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 Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter?

Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter is a medical device that received FDA 510(k) clearance on 2018-04-11. The listed applicant is Cook Incorporated. The 510(k) number is K173686.

When did Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter receive FDA 510(k) clearance?

Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter received FDA 510(k) clearance on 2018-04-11, under 510(k) number K173686.

Who is the listed applicant for Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter?

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

What is the FDA product code for Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter?

The FDA product code for Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® 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.

NCT06744049Transfer Direct System as a New Method for Embryo TransferRECRUITINGNCT06016582Use of Virtual Reality Medical Hypnosis for Anxiolytic Purposes During Frozen Embryo TransferCOMPLETEDNCT06259084Study to Estimate Seedchrony's Predictive Capacity in the Success of Embryo Implantation.COMPLETEDNCT07522281Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI CyclesNOT_YET_RECRUITINGNCT07769684RCT Study on the Effect of ETN on Live Birth Rate in DOR Patients Undergoing IVF-ETNOT_YET_RECRUITING

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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.K220010Daylily Single Use Sterile Embryo Transfer CatheterShanghai Horizon Medical Technology Co., Ltd.K200248Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft ObturatorsAllwin Medical Devices, Inc.

Official Source

View on FDA Database →

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

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