FDA 510(k) Applications for Medical Device Product Code "MQF"
(Catheter, Assisted Reproduction)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K991266 | 09/09/1999 | ||
| K200248 | Allwin Medical Devices, Inc. | Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators | 07/01/2020 |
| K190522 | Allwin Medical Devices, Inc. | 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 an | 11/14/2019 |
| K120154 | CATHETER RESEARCH, INC. | INTRAUTERINE INSEMINATION (IUI) CATHETER | 03/21/2012 |
| K173686 | Cook Incorporated | Guardia Access Embryo Transfer Catheter Sets and Sydney IVF« Transfer Catheter | 04/11/2018 |
| K180302 | Cook Incorporated | GuardiaÖ Access Malleable Obturator, GuardiaÖ Obturator, Soft-PassÖ Obturator, Soft-Trans Malleable Obturator, GuardiaÖ ETS Embryo-Tested Syringe, Flushing Catheter | 10/24/2018 |
| K172051 | Cook Incorporated | GuardiaÖ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter | 01/10/2018 |
| K173103 | Cook Incorporated | Pivet and Soft-Pass Embryo Transfer Catheter Sets | 04/13/2018 |
| K172321 | Cook Incorporated | Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters | 12/21/2017 |
| K191015 | Cook Incorporated | 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) | 05/17/2019 |
| K163318 | Cook Incorporated | Soules Intrauterine Insemination Catheter | 07/14/2017 |
| K983594 | COOK OB/GYN | EMBRYO TRANSFER CATHETERS/SETS | 12/21/1998 |
| K983590 | COOK OB/GYN | GIFT CATHETER SET/S | 12/21/1998 |
| K983587 | COOK OB/GYN | HYSTEROSCOPIC GIFT CATHETER SETS | 12/16/1998 |
| K983591 | COOK OB/GYN | INTRATUBAL TRANSFER SETS | 12/21/1998 |
| K983595 | COOK OB/GYN | TRANSMYOMETRIAL EMBRYO TRANSFER SET | 02/08/1999 |
| K023379 | COOPER SURGICAL | COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION CATHETER | 12/11/2002 |
| K023383 | COOPER SURGICAL | COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER | 12/13/2002 |
| K023382 | COOPER SURGICAL | COOPERSURGICAL MALLEABLE SYTLET | 12/20/2002 |
| K023384 | COOPER SURGICAL | COOPERSURGICAL TRIAL TRANSFER CATHETER | 12/13/2002 |
| K990350 | COOPERSURGICAL, INC. | WALLACE CATHETERS-18CM, MODEL 1816; 23CM, MODEL 1816N; 23CM, MODEL 2316 | 07/26/1999 |
| K990349 | COOPERSURGICAL, INC. | WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST | 07/26/1999 |
| K990348 | COOPERSURGICAL, INC. | WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N | 07/26/1999 |
| K162064 | CrossBay Medical Inc. | CrossBay IVF Embryo Transfer Catheter Set | 01/05/2017 |
| K231730 | Femasys Inc. | FemaSeed Intratubal Insemination | 09/22/2023 |
| K141666 | FERTILIGENT, LTD | FERTILIGENT SLOW RELEASE IUI CATHETER KIT | 02/03/2015 |
| K092579 | FERTILIGENT, LTD | INTRAUTERINE INSEMINATION (IUI) CATHETER | 04/02/2010 |
| K992307 | FERTILITY TECHNOLOGY RESOURCES, INC. | EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CATHETER | 09/13/1999 |
| K041470 | FERTILITY TECHNOLOGY RESOURCES, INC. | MORTON IUI CATHETERS | 11/22/2004 |
| K023017 | FERTILITY TECHNOLOGY RESOURCES, INC. | TUCKER EMBRYO CATHETER | 12/13/2002 |
| K013536 | GYNETICS MEDICAL PRODUCTS NV | EMTRAC; DELPHIN; SEMTRAC 2000 SET | 11/30/2001 |
| K013501 | GYNETICS MEDICAL PRODUCTS NV | IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B | 11/30/2001 |
| K050521 | INNTEC, INC. | EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S | 05/02/2005 |
| K052059 | INNTEC, INC. | IUI CATHETER, MODEL 9057 | 11/22/2005 |
| K162878 | Kitazato Corporation | Kitazato ET Catheters | 07/13/2017 |
| K192540 | Kitazato Corporation | Kitazato ET Catheters | 05/01/2020 |
| K162667 | Kitazato Corporation | Kitazato IUI Catheter | 05/11/2017 |
| K112396 | KITAZATO MEDICAL CO., LTD. | IUI CATHETERS | 11/02/2012 |
| K131491 | KITAZATO MEDICAL CO., LTD. | KITAZATO IUI CATHETER | 09/11/2013 |
| K000950 | LABOTECT LABOR-TECHNIK GOTTINGEN | EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201 | 05/12/2000 |
| K143669 | MEDGYN PRODUCTS, INC. | MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter | 11/23/2015 |
| K161547 | ORIGIO A/S | Transem and EchoGen Embryo Transfer Catheters | 03/09/2017 |
| K033084 | PORTEX LTD. | WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER | 12/19/2003 |
| K000656 | ROCKET MEDICAL PLC | EMBRYON GIFT TRANSFER CATHETERS/SETS | 03/09/2000 |
| K994327 | ROCKET MEDICAL PLC | EMBRYON TRANSFER CATHETERS/SETS | 02/28/2000 |
| K220010 | Shanghai Horizon Medical Technology Co., Ltd. | Daylily Single Use Sterile Embryo Transfer Catheter | 12/16/2022 |
| K053208 | SWEMED LAB INTERNATIONAL AB | CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007; CLEAR VISION TRIAL TRANSFER CATHETER SET | 01/30/2006 |
| K012220 | TTJ BIOMEDICAL, LLC. | TAO EMBRYO TRANSFER CATHETER SYSTEM | 08/27/2001 |
| K983604 | WASHINGTON REGULATORY SERVICES | INTRA-UTERINE TRANSFER, INTRA-FOLOPIAN TRANSFER | 05/27/1999 |
| K173431 | William A. Cook Australia PTY LTD | Towako Transmyometrial Embryo Transfer Set | 05/18/2018 |
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