MQF — Catheter, Assisted Reproduction Class II

FDA Device Classification

Classification Details

Product Code
MQF
Device Class
Class II
Regulation Number
884.6110
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K253354guangzhou hehong biotech coMinvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175February 12, 2026
K243373vitrolife swedenEmbryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter -July 23, 2025
K240307shenzhen vitavitro biotech coVitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)August 16, 2024
K231730femasysFemaSeed Intratubal InseminationSeptember 22, 2023
K220010shanghai horizon medical technology coDaylily Single Use Sterile Embryo Transfer CatheterDecember 16, 2022
K200248allwin medical devicesAllwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft ObturatorsJuly 1, 2020
K192540kitazato corporationKitazato ET CathetersMay 1, 2020
K190522allwin medical devicesAllwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip IntrNovember 14, 2019
K191015cook incorporatedSoft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer CatMay 17, 2019
K180302cook incorporatedGuardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, SOctober 24, 2018
K173431william a. cook australia pty.Towako Transmyometrial Embryo Transfer SetMay 18, 2018
K173103cook incorporatedPivet and Soft-Pass Embryo Transfer Catheter SetsApril 13, 2018
K173686cook incorporatedGuardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer CatheterApril 11, 2018
K172051cook incorporatedGuardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans EmJanuary 10, 2018
K172321cook incorporatedShepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination CatDecember 21, 2017
K163318cook incorporatedSoules Intrauterine Insemination CatheterJuly 14, 2017
K162878kitazato corporationKitazato ET CathetersJuly 13, 2017
K162667kitazato corporationKitazato IUI CatheterMay 11, 2017
K161547origioTransem and EchoGen Embryo Transfer CathetersMarch 9, 2017
K162064crossbay medicalCrossBay IVF Embryo Transfer Catheter SetJanuary 5, 2017