Catheter, Assisted Reproduction

FDA product code MQF · 51 cleared devices

Class 2 Obstetrics/Gynecology

Regulation: 21 CFR 884.6110
Review panel: OB
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1998-12-16 – 2026-02-12

MQF 2026-02-12

Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)

Applicant Guangzhou Hehong Biotech Co., Ltd.

K number K253354

View details →

MQF 2025-07-23

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

K number K243373

View details →

MQF 2024-08-16

VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)

Applicant Shenzhen Vitavitro Biotech Co., Ltd.

K number K240307

View details →

MQF 2023-09-22

FemaSeed Intratubal Insemination

Applicant Femasys, Inc.

K number K231730

View details →

MQF 2022-12-16

Daylily Single Use Sterile Embryo Transfer Catheter

Applicant Shanghai Horizon Medical Technology Co., Ltd.

K number K220010

View details →

MQF 2020-07-01

Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators

Applicant Allwin Medical Devices, Inc.

K number K200248

View details →

MQF 2020-05-01

Kitazato ET Catheters

Applicant Kitazato Corporation

K number K192540

View details →

MQF 2019-11-14

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)

Applicant Allwin Medical Devices, Inc.

K number K190522

View details →

MQF 2019-05-17

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)

Applicant Cook Incorporated

K number K191015

View details →

MQF 2018-10-24

Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter

Applicant Cook Incorporated

K number K180302

View details →

MQF 2018-05-18

Towako Transmyometrial Embryo Transfer Set

Applicant William A. Cook Australia Pty. , Ltd.

K number K173431

View details →

MQF 2018-04-13

Pivet and Soft-Pass Embryo Transfer Catheter Sets

Applicant Cook Incorporated

K number K173103

View details →

MQF 2018-04-11

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

Applicant Cook Incorporated

K number K173686

View details →

MQF 2018-01-10

Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter

Applicant Cook Incorporated

K number K172051

View details →

MQF 2017-12-21

Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters

Applicant Cook Incorporated

K number K172321

View details →

MQF 2017-07-14

Soules Intrauterine Insemination Catheter

Applicant Cook Incorporated

K number K163318

View details →

MQF 2017-07-13

Kitazato ET Catheters

Applicant Kitazato Corporation

K number K162878

View details →

MQF 2017-05-11

Kitazato IUI Catheter

Applicant Kitazato Corporation

K number K162667

View details →

MQF 2017-03-09

Transem and EchoGen Embryo Transfer Catheters

Applicant Origio A/S

K number K161547

View details →

MQF 2017-01-05

CrossBay IVF Embryo Transfer Catheter Set

Applicant Crossbay Medical, Inc.

K number K162064

View details →

MQF 2013-09-11

KITAZATO IUI CATHETER

Applicant Kitazato Medical Co., Ltd.

K number K131491

View details →

MQF 2012-11-02

IUI CATHETERS

Applicant Kitazato Medical Co., Ltd.

K number K112396

View details →

MQF 2012-03-21

INTRAUTERINE INSEMINATION (IUI) CATHETER

Applicant Catheter Research, Inc.

K number K120154

View details →

MQF 2010-04-02

INTRAUTERINE INSEMINATION (IUI) CATHETER

Applicant Fertiligent, Ltd.

K number K092579

View details →

MQF 2006-01-30

CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007; CLEAR VISION TRIAL TRANSFER CATHETER SET

Applicant Swemed Lab International AB

K number K053208

View details →

MQF 2005-11-22

IUI CATHETER, MODEL 9057

Applicant Inntec, Inc.

K number K052059

View details →

MQF 2005-05-02

EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S

Applicant Inntec, Inc.

K number K050521

View details →

MQF 2004-11-22

MORTON IUI CATHETERS

Applicant Fertility Technology Resources, Inc.

K number K041470

View details →

MQF 2003-12-19

WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER

Applicant Portex , Ltd.

K number K033084

View details →

MQF 2002-12-20

COOPERSURGICAL MALLEABLE SYTLET

Applicant Cooper Surgical

K number K023382

View details →

MQF 2002-12-13

COOPERSURGICAL TRIAL TRANSFER CATHETER

Applicant Cooper Surgical

K number K023384

View details →

MQF 2002-12-13

COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER

Applicant Cooper Surgical

K number K023383

View details →

MQF 2002-12-13

TUCKER EMBRYO CATHETER

Applicant Fertility Technology Resources, Inc.

K number K023017

View details →

MQF 2002-12-11

COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION CATHETER

Applicant Cooper Surgical

K number K023379

View details →

MQF 2001-11-30

EMTRAC; DELPHIN; SEMTRAC 2000 SET

Applicant Gynetics Medical Products NV

K number K013536

View details →

MQF 2001-11-30

IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B

Applicant Gynetics Medical Products NV

K number K013501

View details →

MQF 2001-08-27

TAO EMBRYO TRANSFER CATHETER SYSTEM

Applicant Ttj Biomedical, LLC

K number K012220

View details →

MQF 2000-05-12

EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201

Applicant Labotect Labor-Technik Gottingen

K number K000950

View details →

MQF 2000-03-09

EMBRYON GIFT TRANSFER CATHETERS/SETS

Applicant Rocket Medical Plc

K number K000656

View details →

MQF 2000-02-28

EMBRYON TRANSFER CATHETERS/SETS

Applicant Rocket Medical Plc

K number K994327

View details →

MQF 1999-09-13

EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CATHETER

Applicant Fertility Technology Resources, Inc.

K number K992307

View details →

MQF 1999-09-09

<GENX> EMBRYO TRANSFER CATHETER CC GLIDER

Applicant <Genx> Intl., Inc.

K number K991266

View details →

MQF 1999-07-26

WALLACE CATHETERS-18CM, MODEL 1816; 23CM, MODEL 1816N; 23CM, MODEL 2316

Applicant CooperSurgical, Inc.

K number K990350

View details →

MQF 1999-07-26

WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST

Applicant CooperSurgical, Inc.

K number K990349

View details →

MQF 1999-07-26

WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N

Applicant CooperSurgical, Inc.

K number K990348

View details →

MQF 1999-05-27

INTRA-UTERINE TRANSFER, INTRA-FOLOPIAN TRANSFER

Applicant Washington Regulatory Services

K number K983604

View details →

MQF 1999-02-08

TRANSMYOMETRIAL EMBRYO TRANSFER SET

Applicant Cook Ob/Gyn

K number K983595

View details →

MQF 1998-12-21

EMBRYO TRANSFER CATHETERS/SETS

Applicant Cook Ob/Gyn

K number K983594

View details →

MQF 1998-12-21

INTRATUBAL TRANSFER SETS

Applicant Cook Ob/Gyn

K number K983591

View details →

MQF 1998-12-21

GIFT CATHETER SET/S

Applicant Cook Ob/Gyn

K number K983590

View details →

MQF 1998-12-16

HYSTEROSCOPIC GIFT CATHETER SETS

Applicant Cook Ob/Gyn

K number K983587

View details →