FDA Product Code
FDA Product Code MQF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.6110
510(k) Clearances — 53 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253354 | Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) | Guangzhou Hehong Biotech Co., Ltd. | 2026-02-12 | Traditional | PDF ↗ |
| K243373 | 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) | Vitrolife Sweden AB | 2025-07-23 | Traditional | PDF ↗ |
| K240307 | VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) | Shenzhen Vitavitro Biotech Co., Ltd. | 2024-08-16 | Traditional | PDF ↗ |
| K231730 | FemaSeed Intratubal Insemination | Femasys, Inc. | 2023-09-22 | Traditional | PDF ↗ |
| K220010 | Daylily Single Use Sterile Embryo Transfer Catheter | Shanghai Horizon Medical Technology Co., Ltd. | 2022-12-16 | Traditional | PDF ↗ |
| K200248 | Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators | Allwin Medical Devices, Inc. | 2020-07-01 | Traditional | PDF ↗ |
| K192540 | Kitazato ET Catheters | Kitazato Corporation | 2020-05-01 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| 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 | Special | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K173431 | Towako Transmyometrial Embryo Transfer Set | William A. Cook Australia Pty. , Ltd. | 2018-05-18 | Special | PDF ↗ |
| K173103 | Pivet and Soft-Pass Embryo Transfer Catheter Sets | Cook Incorporated | 2018-04-13 | Traditional | PDF ↗ |
| K173686 | Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter | Cook Incorporated | 2018-04-11 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K172321 | Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters | Cook Incorporated | 2017-12-21 | Special | PDF ↗ |
| K163318 | Soules Intrauterine Insemination Catheter | Cook Incorporated | 2017-07-14 | Traditional | PDF ↗ |
| K162878 | Kitazato ET Catheters | Kitazato Corporation | 2017-07-13 | Traditional | PDF ↗ |
| K162667 | Kitazato IUI Catheter | Kitazato Corporation | 2017-05-11 | Traditional | PDF ↗ |
| K161547 | Transem and EchoGen Embryo Transfer Catheters | Origio A/S | 2017-03-09 | Traditional | PDF ↗ |
| K162064 | CrossBay IVF Embryo Transfer Catheter Set | Crossbay Medical, Inc. | 2017-01-05 | Traditional | PDF ↗ |
| K143669 | MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter | Medgyn Products, Inc. | 2015-11-23 | Traditional | PDF ↗ |
| K141666 | FERTILIGENT SLOW RELEASE IUI CATHETER KIT | Fertiligent, Ltd. | 2015-02-03 | Traditional | PDF ↗ |
| K131491 | KITAZATO IUI CATHETER | Kitazato Medical Co., Ltd. | 2013-09-11 | Traditional | PDF ↗ |
| K112396 | IUI CATHETERS | Kitazato Medical Co., Ltd. | 2012-11-02 | Traditional | PDF ↗ |
| K120154 | INTRAUTERINE INSEMINATION (IUI) CATHETER | Catheter Research, Inc. | 2012-03-21 | Abbreviated | PDF ↗ |
| K092579 | INTRAUTERINE INSEMINATION (IUI) CATHETER | Fertiligent, Ltd. | 2010-04-02 | Traditional | PDF ↗ |
| K053208 | CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007; CLEAR VISION TRIAL TRANSFER CATHETER SET | Swemed Lab International AB | 2006-01-30 | Abbreviated | PDF ↗ |
| K052059 | IUI CATHETER, MODEL 9057 | Inntec, Inc. | 2005-11-22 | Abbreviated | PDF ↗ |
| K050521 | EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S | Inntec, Inc. | 2005-05-02 | Abbreviated | PDF ↗ |
| K041470 | MORTON IUI CATHETERS | Fertility Technology Resources, Inc. | 2004-11-22 | Traditional | PDF ↗ |
| K033084 | WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER | Portex , Ltd. | 2003-12-19 | Traditional | PDF ↗ |
| K023382 | COOPERSURGICAL MALLEABLE SYTLET | Cooper Surgical | 2002-12-20 | Traditional | PDF ↗ |
| K023017 | TUCKER EMBRYO CATHETER | Fertility Technology Resources, Inc. | 2002-12-13 | Traditional | PDF ↗ |
| K023384 | COOPERSURGICAL TRIAL TRANSFER CATHETER | Cooper Surgical | 2002-12-13 | Traditional | PDF ↗ |
| K023383 | COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER | Cooper Surgical | 2002-12-13 | Traditional | PDF ↗ |
| K023379 | COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION CATHETER | Cooper Surgical | 2002-12-11 | Traditional | PDF ↗ |
| K013536 | EMTRAC; DELPHIN; SEMTRAC 2000 SET | Gynetics Medical Products NV | 2001-11-30 | Traditional | PDF ↗ |
| K013501 | IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B | Gynetics Medical Products NV | 2001-11-30 | Traditional | PDF ↗ |
| K012220 | TAO EMBRYO TRANSFER CATHETER SYSTEM | Ttj Biomedical, LLC | 2001-08-27 | Traditional | PDF ↗ |
| K000950 | EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201 | Labotect Labor-Technik Gottingen | 2000-05-12 | Traditional | PDF ↗ |
| K000656 | EMBRYON GIFT TRANSFER CATHETERS/SETS | Rocket Medical Plc | 2000-03-09 | Traditional | PDF ↗ |
| K994327 | EMBRYON TRANSFER CATHETERS/SETS | Rocket Medical Plc | 2000-02-28 | Traditional | PDF ↗ |
| K992307 | EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CATHETER | Fertility Technology Resources, Inc. | 1999-09-13 | Traditional | PDF ↗ |
| K991266 | <GENX> EMBRYO TRANSFER CATHETER CC GLIDER | <Genx> Intl., Inc. | 1999-09-09 | Traditional | PDF ↗ |
| K990349 | WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST | CooperSurgical, Inc. | 1999-07-26 | Traditional | PDF ↗ |
| K990350 | WALLACE CATHETERS-18CM, MODEL 1816; 23CM, MODEL 1816N; 23CM, MODEL 2316 | CooperSurgical, Inc. | 1999-07-26 | Traditional | PDF ↗ |
| K990348 | WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N | CooperSurgical, Inc. | 1999-07-26 | Traditional | PDF ↗ |
| K983604 | INTRA-UTERINE TRANSFER, INTRA-FOLOPIAN TRANSFER | Washington Regulatory Services | 1999-05-27 | Traditional | PDF ↗ |
| K983595 | TRANSMYOMETRIAL EMBRYO TRANSFER SET | Cook Ob/Gyn | 1999-02-08 | Traditional | PDF ↗ |
| K983590 | GIFT CATHETER SET/S | Cook Ob/Gyn | 1998-12-21 | Traditional | PDF ↗ |
| K983591 | INTRATUBAL TRANSFER SETS | Cook Ob/Gyn | 1998-12-21 | Traditional | PDF ↗ |
| K983594 | EMBRYO TRANSFER CATHETERS/SETS | Cook Ob/Gyn | 1998-12-21 | Traditional | PDF ↗ |
| K983587 | HYSTEROSCOPIC GIFT CATHETER SETS | Cook Ob/Gyn | 1998-12-16 | Traditional | PDF ↗ |
Product code MQF · Class II · Obstetrics/Gynecology. Data: openFDA.