ClearanceBrief
Panels › Obstetrics/Gynecology › Product code MQF · Class 2

Catheter, Assisted Reproduction

Regulation 884.6110

1510(k)s in 12 months (53 all time)
0recalls in 12 months (36 all time)
13recalls that name a 510(k)
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Top companies in MQF

Company510(k)sRecalls
Tenderneeds Fertility LLC019
Cook Incorporated75
Fertility Technology Resources, Inc.36
Smiths Medical ASD, Inc.06
Cook Ob/Gyn50
Cooper Surgical40
CooperSurgical, Inc.30
Kitazato Corporation30
Allwin Medical Devices, Inc.20
Fertiligent, Ltd.20
Decided510(k)Device and applicantCode
Feb 12, 2026K253354Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)
Guangzhou Hehong Biotech Co., Ltd., CN
MQF
Jul 23, 2025K243373Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCa
Vitrolife Sweden AB, SE
MQF
Aug 16, 2024K240307VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)
Shenzhen Vitavitro Biotech Co., Ltd., CN
MQF
Sep 22, 2023K231730FemaSeed Intratubal Insemination
Femasys, Inc.
MQF
Dec 16, 2022K220010Daylily Single Use Sterile Embryo Transfer Catheter
Shanghai Horizon Medical Technology Co., Ltd., CN
MQF
Jul 1, 2020K200248Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators
Allwin Medical Devices, Inc.
MQF
May 1, 2020K192540Kitazato ET Catheters
Kitazato Corporation, JP
MQF
Nov 14, 2019K190522Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED
Allwin Medical Devices, Inc.
MQF
May 17, 2019K191015Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Tran
Cook Incorporated
MQF
Oct 24, 2018K180302Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™
Cook Incorporated
MQF
May 18, 2018K173431Towako Transmyometrial Embryo Transfer Set
William A. Cook Australia Pty. , Ltd., AU
MQF
Apr 13, 2018K173103Pivet and Soft-Pass Embryo Transfer Catheter Sets
Cook Incorporated
MQF
Apr 11, 2018K173686Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter
Cook Incorporated
MQF
Jan 10, 2018K172051Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide
Cook Incorporated
MQF
Dec 21, 2017K172321Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters
Cook Incorporated
MQF
Jul 14, 2017K163318Soules Intrauterine Insemination Catheter
Cook Incorporated
MQF
Jul 13, 2017K162878Kitazato ET Catheters
Kitazato Corporation, JP
MQF
May 11, 2017K162667Kitazato IUI Catheter
Kitazato Corporation, JP
MQF
Mar 9, 2017K161547Transem and EchoGen Embryo Transfer Catheters
Origio A/S, DK
MQF
Jan 5, 2017K162064CrossBay IVF Embryo Transfer Catheter Set
Crossbay Medical, Inc.
MQF
Nov 23, 2015K143669MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter
Medgyn Products, Inc.
MQF
Feb 3, 2015K141666FERTILIGENT SLOW RELEASE IUI CATHETER KIT
Fertiligent, Ltd.
MQF
Sep 11, 2013K131491KITAZATO IUI CATHETER
Kitazato Medical Co., Ltd.
MQF
Nov 2, 2012K112396IUI CATHETERS
Kitazato Medical Co., Ltd.
MQF
Mar 21, 2012K120154INTRAUTERINE INSEMINATION (IUI) CATHETER
Catheter Research, Inc.
MQF
Apr 2, 2010K092579INTRAUTERINE INSEMINATION (IUI) CATHETER
Fertiligent, Ltd.
MQF
Jan 30, 2006K053208CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007; CLEAR VISION TRIAL TRANSFER CATHETER SET
Swemed Lab International AB, SE
MQF
Nov 22, 2005K052059IUI CATHETER, MODEL 9057
Inntec, Inc.
MQF
May 2, 2005K050521EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S
Inntec, Inc.
MQF
Nov 22, 2004K041470MORTON IUI CATHETERS
Fertility Technology Resources, Inc.
MQF
Dec 19, 2003K033084WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER
Portex , Ltd., GB
MQF
Dec 20, 2002K023382COOPERSURGICAL MALLEABLE SYTLET
Cooper Surgical
MQF
Dec 13, 2002K023384COOPERSURGICAL TRIAL TRANSFER CATHETER
Cooper Surgical
MQF
Dec 13, 2002K023383COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER
Cooper Surgical
MQF
Dec 13, 2002K023017TUCKER EMBRYO CATHETER
Fertility Technology Resources, Inc.
MQF
Dec 11, 2002K023379COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION CATHETER
Cooper Surgical
MQF
Nov 30, 2001K013536EMTRAC; DELPHIN; SEMTRAC 2000 SET
Gynetics Medical Products NV
MQF
Nov 30, 2001K013501IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B
Gynetics Medical Products NV
MQF
Aug 27, 2001K012220TAO EMBRYO TRANSFER CATHETER SYSTEM
Ttj Biomedical, LLC
MQF
May 12, 2000K000950EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201
Labotect Labor-Technik Gottingen, DE
MQF
Mar 9, 2000K000656EMBRYON GIFT TRANSFER CATHETERS/SETS
Rocket Medical Plc, GB
MQF
Feb 28, 2000K994327EMBRYON TRANSFER CATHETERS/SETS
Rocket Medical Plc, GB
MQF
Sep 13, 1999K992307EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CATHETER
Fertility Technology Resources, Inc.
MQF
Sep 9, 1999K991266<GENX> EMBRYO TRANSFER CATHETER CC GLIDER
<Genx> Intl., Inc.
MQF
Jul 26, 1999K990350WALLACE CATHETERS-18CM, MODEL 1816; 23CM, MODEL 1816N; 23CM, MODEL 2316
CooperSurgical, Inc.
MQF
Jul 26, 1999K990349WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST
CooperSurgical, Inc.
MQF
Jul 26, 1999K990348WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N
CooperSurgical, Inc.
MQF
May 27, 1999K983604INTRA-UTERINE TRANSFER, INTRA-FOLOPIAN TRANSFER
Washington Regulatory Services
MQF
Feb 8, 1999K983595TRANSMYOMETRIAL EMBRYO TRANSFER SET
Cook Ob/Gyn
MQF
Dec 21, 1998K983594EMBRYO TRANSFER CATHETERS/SETS
Cook Ob/Gyn
MQF

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