510(k) K243373

Device: 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 Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511)
Applicant: Vitrolife Sweden AB
510(k) number: K243373
Product code: MQF
Decision: Substantially Equivalent (SESE)
Decision date: 2025-07-23
Date received: 2024-10-30
Regulation: 884.6110
Classification name: Catheter, Assisted Reproduction
Medical specialty: Obstetrics/Gynecology
Review panel: Obstetrics/Gynecology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Ann-Cathrine Ericson
Address: Gustaf Werners Gata 2 Västra Frölunda SE 421 32 421 32

FDA Registration Numbers

1450662
3007800906
1825146
3009756327
3015136743
3003775072
1221433
1450908
3014755376
3003995932
9610632
1422634
3014295858
3015453963
9617744
3005941719
3008876063
3005580113
9612445
1018470
1216677
3010155661
3017247483
3017896194
3043639843
3005136445
1047843
3030447506
8043478
3008456389
2246552
3009337401
1000393132
1820334
1424263
3005987240
9611680
3015140190

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code MQF

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
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 Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter)	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