Product code MQF

Device name: Catheter, Assisted Reproduction
Medical specialty: Obstetrics/Gynecology
Device class: 2
Regulation number: 884.6110
Review panel: OB
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K253354	Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)	Guangzhou Hehong Biotech Co., Ltd.	2026-02-12
K243373	Embryo 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 M...	Vitrolife Sweden AB	2025-07-23
K240307	VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)	Shenzhen Vitavitro Biotech Co., Ltd.	2024-08-16
K231730	FemaSeed Intratubal Insemination	Femasys, Inc.	2023-09-22
K220010	Daylily Single Use Sterile Embryo Transfer Catheter	Shanghai Horizon Medical Technology Co., Ltd.	2022-12-16
K200248	Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators	Allwin Medical Devices, Inc.	2020-07-01
K192540	Kitazato ET Catheters	Kitazato Corporation	2020-05-01
K190522	Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination ...	Allwin Medical Devices, Inc.	2019-11-14
K191015	Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip)	Cook Incorporated	2019-05-17
K180302	Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter	Cook Incorporated	2018-10-24
K173431	Towako Transmyometrial Embryo Transfer Set	William A. Cook Australia Pty. , Ltd.	2018-05-18
K173103	Pivet and Soft-Pass Embryo Transfer Catheter Sets	Cook Incorporated	2018-04-13
K173686	Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter	Cook Incorporated	2018-04-11
K172051	Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter	Cook Incorporated	2018-01-10
K172321	Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters	Cook Incorporated	2017-12-21
K163318	Soules Intrauterine Insemination Catheter	Cook Incorporated	2017-07-14
K162878	Kitazato ET Catheters	Kitazato Corporation	2017-07-13
K162667	Kitazato IUI Catheter	Kitazato Corporation	2017-05-11
K161547	Transem and EchoGen Embryo Transfer Catheters	Origio A/S	2017-03-09
K162064	CrossBay IVF Embryo Transfer Catheter Set	Crossbay Medical, Inc.	2017-01-05
K143669	MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter	Medgyn Products, Inc.	2015-11-23
K141666	FERTILIGENT SLOW RELEASE IUI CATHETER KIT	Fertiligent, Ltd.	2015-02-03
K131491	KITAZATO IUI CATHETER	Kitazato Medical Co., Ltd.	2013-09-11
K112396	IUI CATHETERS	Kitazato Medical Co., Ltd.	2012-11-02
K120154	INTRAUTERINE INSEMINATION (IUI) CATHETER	Catheter Research, Inc.	2012-03-21
K092579	INTRAUTERINE INSEMINATION (IUI) CATHETER	Fertiligent, Ltd.	2010-04-02
K053208	CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007; CLEAR VISION TRIAL TRANSFER CATHETER SET	Swemed Lab International AB	2006-01-30
K052059	IUI CATHETER, MODEL 9057	Inntec, Inc.	2005-11-22
K050521	EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S	Inntec, Inc.	2005-05-02
K041470	MORTON IUI CATHETERS	Fertility Technology Resources, Inc.	2004-11-22

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
M803TMI1297	Clear Shapeable Intrauterine Insemination catheter	MEDGYN PRODUCTS, INC.	2024-01-03
30859500005104	FemaSeed	FEMASYS INC.	2023-11-29
20859500005107	FemaSeed	FEMASYS INC.	2023-11-28
00812261016894	Embryo Trans Embryo Transfer Catheter 23cm	ALLWIN MEDICAL DEVICES, INC.	2020-09-18
00812261016849	Pro Embryo Trans with Soft Obturator	ALLWIN MEDICAL DEVICES, INC.	2020-09-18
00812261016832	Bulb Trans Ultra Embryo Transfer Catheter	ALLWIN MEDICAL DEVICES, INC.	2020-09-18
00812261016634	Soft Obturator for Pro Embryo Trans	ALLWIN MEDICAL DEVICES, INC.	2020-09-18
00812261016580	Stylet for Bulb Trans Ultra/ Bulb Trans Star Embryo Transfer Catheter - Bulb Tip	ALLWIN MEDICAL DEVICES, INC.	2020-09-18
00812261016573	Stylet for Embryo Trans/Twinkle Embryo Trans (18cm)	ALLWIN MEDICAL DEVICES, INC.	2020-09-18
00812261016566	Stylet for Embryo Trans 23cm/ Stylet for Twinkle Embryo Trans 23cm	ALLWIN MEDICAL DEVICES, INC.	2020-09-18
00812261016559	Embryo Trans Embryo Transfer Catheter 18cm	ALLWIN MEDICAL DEVICES, INC.	2020-09-18
15019315012471	Portex	ICU MEDICAL, INC.	2017-10-23
15019315012464	Portex	ICU MEDICAL, INC.	2017-10-23
15019315012587	Portex	ICU MEDICAL, INC.	2017-10-23
15019315012594	Portex	ICU MEDICAL, INC.	2017-10-23
15019315056680	Wallace	ICU MEDICAL, INC.	2016-12-07
15019315056543	Wallace	ICU MEDICAL, INC.	2016-12-07
15019315056697	Wallace	ICU MEDICAL, INC.	2016-12-07
15019315056673	Wallace	ICU MEDICAL, INC.	2016-12-07
15019315015724	Wallace	ICU MEDICAL, INC.	2016-10-11
15019315015687	Wallace	ICU MEDICAL, INC.	2016-10-11
15019315015670	Wallace	ICU MEDICAL, INC.	2016-10-11
15019315015663	Wallace	ICU MEDICAL, INC.	2016-10-05
15019315015656	Wallace	ICU MEDICAL, INC.	2016-10-05
15019315015625	Wallace	ICU MEDICAL, INC.	2016-10-05
15019315015618	Wallace	ICU MEDICAL, INC.	2016-10-05
15019315056710	Wallace	ICU MEDICAL, INC.	2016-10-05
M803022724	MedGyn IUI	MEDGYN PRODUCTS, INC.	2016-09-08
M803022725	MedGyn IUI	MEDGYN PRODUCTS, INC.	2016-09-08
M803022723	MedGyn IUI catheter	MEDGYN PRODUCTS, INC.	2016-09-08

Product code MQF

Related 510(k) Records#

Related GUDID Devices#