Catheter, Assisted Reproduction
FDA product code MQF · Class II (moderate risk) · 21 CFR 884.6110 · Obstetrics/Gynecology
53510(k) clearances
0PMA approvals
36recalls
Manufacturers
- Cook, Inc. 7
- Cook Ob/Gyn 5
- Cooper Surgical, Inc. 4
- CooperSurgical, Inc. 3
- Kitazato Corporation 3
- Fertility Technology Resources, Inc. 3
- Rocket Medical Plc 2
- Allwin Medical Devices, Inc. 2
- Gynetics Medical Products NV 2
- Inntec, Inc. 2
- Fertiligent, Ltd. 2
- Kitazato Medical Co., Ltd. 2
- Portex, Inc. 1
- Guangzhou Hehong Biotech Co., Ltd. 1
- Medgyn Products, Inc. 1
- Catheter Research, Inc. 1
- Swemed Lab International AB 1
- Ttj Biomedical, LLC 1
- Labotect Labor-Technik Gottingen 1
- <Genx> Intl., Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253354 | Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C…MQF · Traditional | Guangzhou Hehong Biotech Co., Ltd. | 02/12/2026SE |
| K243373 | Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter -…MQF · Traditional | Vitrolife Sweden AB | 07/23/2025SE |
| K240307 | VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)MQF · Traditional | Shenzhen Vitavitro Biotech Co., Ltd. | 08/16/2024SE |
| K231730 | FemaSeed Intratubal InseminationMQF · Traditional | Femasys, Inc. | 09/22/2023SE |
| K220010 | Daylily Single Use Sterile Embryo Transfer CatheterMQF · Traditional | Shanghai Horizon Medical Technology Co., Ltd. | 12/16/2022SE |
| K200248 | Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft ObturatorsMQF · Traditional | Allwin Medical Devices, Inc. | 07/01/2020SE |
| K192540 | Kitazato ET CathetersMQF · Traditional | Kitazato Corporation | 05/01/2020SE |
| K190522 | Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra…MQF · Traditional | Allwin Medical Devices, Inc. | 11/14/2019SE |
| K191015 | Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter…MQF · Special | Cook Incorporated | 05/17/2019SE |
| K180302 | Guardia Access Malleable Obturator, Guardia Obturator, Soft-Pass Obturator…MQF · Traditional | Cook Incorporated | 10/24/2018SE |
| K173431 | Towako Transmyometrial Embryo Transfer SetMQF · Special | William A. Cook Australia Pty. , Ltd. | 05/18/2018SE |
| K173103 | Pivet and Soft-Pass Embryo Transfer Catheter SetsMQF · Traditional | Cook Incorporated | 04/13/2018SE |
| K173686 | Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer CatheterMQF · Traditional | Cook Incorporated | 04/11/2018SE |
| K172051 | Guardia Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo…MQF · Traditional | Cook Incorporated | 01/10/2018SE |
| K172321 | Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination CathetersMQF · Special | Cook Incorporated | 12/21/2017SE |
| K163318 | Soules Intrauterine Insemination CatheterMQF · Traditional | Cook Incorporated | 07/14/2017SE |
| K162878 | Kitazato ET CathetersMQF · Traditional | Kitazato Corporation | 07/13/2017SE |
| K162667 | Kitazato IUI CatheterMQF · Traditional | Kitazato Corporation | 05/11/2017SE |
| K161547 | Transem and EchoGen Embryo Transfer CathetersMQF · Traditional | Origio A/S | 03/09/2017SE |
| K162064 | CrossBay IVF Embryo Transfer Catheter SetMQF · Traditional | Crossbay Medical, Inc. | 01/05/2017SE |
| K143669 | MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI CatheterMQF · Traditional | Medgyn Products, Inc. | 11/23/2015SE |
| K141666 | Fertiligent Slow Release Iui Catheter KitMQF · Traditional | Fertiligent, Ltd. | 02/03/2015SE |
| K131491 | Kitazato Iui CatheterMQF · Traditional | Kitazato Medical Co., Ltd. | 09/11/2013SE |
| K112396 | Iui CathetersMQF · Traditional | Kitazato Medical Co., Ltd. | 11/02/2012SE |
| K120154 | Intrauterine Insemination (Iui) CatheterMQF · Abbreviated | Catheter Research, Inc. | 03/21/2012SE |
| K092579 | Intrauterine Insemination (Iui) CatheterMQF · Traditional | Fertiligent, Ltd. | 04/02/2010SE |
| K053208 | Clear Vision Embryo Transfer Catheter Set, Model B100000 - B 100007; Clear Vision Trial…MQF · Abbreviated | Swemed Lab International AB | 01/30/2006SE |
| K052059 | Iui Catheter, Model 9057MQF · Abbreviated | Inntec, Inc. | 11/22/2005SE |
| K050521 | Embryo Transfer Catheter with Accessory Stylet, Models 9018, 9023, 9018-S, 9023-SMQF · Abbreviated | Inntec, Inc. | 05/02/2005SE |
| K041470 | Morton Iui CathetersMQF · Traditional | Fertility Technology Resources, Inc. | 11/22/2004SE |
| K033084 | Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer CatheterMQF · Traditional | Portex , Ltd. | 12/19/2003SE |
| K023382 | Coopersurgical Malleable SytletMQF · Traditional | Cooper Surgical | 12/20/2002SE |
| K023384 | Coopersurgical Trial Transfer CatheterMQF · Traditional | Cooper Surgical | 12/13/2002SE |
| K023383 | Coopersurgical Intrauterine Insemination CatheterMQF · Traditional | Cooper Surgical | 12/13/2002SE |
| K023017 | Tucker Embryo CatheterMQF · Traditional | Fertility Technology Resources, Inc. | 12/13/2002SE |
| K023379 | Coopersurgical Embryo Transfer Catheter, Coopersurgical Assisted Reproduction CatheterMQF · Traditional | Cooper Surgical | 12/11/2002SE |
| K013536 | Emtrac; Delphin; Semtrac 2000 SetMQF · Traditional | Gynetics Medical Products NV | 11/30/2001SE |
| K013501 | Iui, Model 4220; Smooze, Model 4225, L; Seminor, Model 4502 a, BMQF · Traditional | Gynetics Medical Products NV | 11/30/2001SE |
| K012220 | Tao Embryo Transfer Catheter SystemMQF · Traditional | Ttj Biomedical, LLC | 08/27/2001SE |
| K000950 | Embryo Transfer Catheter Set, Model 320200 and 320201MQF · Traditional | Labotect Labor-Technik Gottingen | 05/12/2000SE |
| K000656 | Embryon Gift Transfer Catheters/SetsMQF · Traditional | Rocket Medical Plc | 03/09/2000SE |
| K994327 | Embryon Transfer Catheters/SetsMQF · Traditional | Rocket Medical Plc | 02/28/2000SE |
| K992307 | Embryo Glide Embryo Transfer Catheter, Embryo Glide Style for Embryo Transfer CatheterMQF · Traditional | Fertility Technology Resources, Inc. | 09/13/1999SE |
| K991266 | <Genx> Embryo Transfer Catheter CC GliderMQF · Traditional | <Genx> Intl., Inc. | 09/09/1999SE |
| K990350 | Wallace CATHETERS-18CM, Model 1816; 23CM, Model 1816N; 23CM, Model 2316MQF · Traditional | CooperSurgical, Inc. | 07/26/1999SE |
| K990349 | Wallace Malleable STYLET-18CM, Model 1816ST, Wallace Malleable STYLET-23CM, Model 1816NSTMQF · Traditional | CooperSurgical, Inc. | 07/26/1999SE |
| K990348 | Wallace Trial Transfer Catheter, Model TT 1816NMQF · Traditional | CooperSurgical, Inc. | 07/26/1999SE |
| K983604 | Intra-Uterine Transfer, Intra-Folopian TransferMQF · Traditional | Washington Regulatory Services | 05/27/1999SE |
| K983595 | Transmyometrial Embryo Transfer SetMQF · Traditional | Cook Ob/Gyn | 02/08/1999SE |
| K983594 | Embryo Transfer Catheters/SetsMQF · Traditional | Cook Ob/Gyn | 12/21/1998SE |
| K983591 | Intratubal Transfer SetsMQF · Traditional | Cook Ob/Gyn | 12/21/1998SE |
| K983590 | Gift Catheter Set/SMQF · Traditional | Cook Ob/Gyn | 12/21/1998SE |
| K983587 | Hysteroscopic Gift Catheter SetsMQF · Traditional | Cook Ob/Gyn | 12/16/1998SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2183-2021 Class II | 2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, SKU unknownDevice was distributed without a proper marketing authorization. This event is an expansion of RES 87581… | Tenderneeds Fertility LLC | 12/23/2020Open, Classified |
| Z-2182-2021 Class II | Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581… | Tenderneeds Fertility LLC | 12/23/2020Open, Classified |
| Z-2181-2021 Class II | Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy &…Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581… | Tenderneeds Fertility LLC | 12/23/2020Open, Classified |
| Z-2180-2021 Class II | TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 133166055771Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581… | Tenderneeds Fertility LLC | 12/23/2020Open, Classified |
| Z-2179-2021 Class II | 2 X Sterile Human Home Artificial Insemination Semen Kit (Human), SKU 143298592960Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581… | Tenderneeds Fertility LLC | 12/23/2020Open, Classified |
| Z-2178-2021 Class II | Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSWDevice was distributed without a proper marketing authorization. This event is an expansion of RES 87581… | Tenderneeds Fertility LLC | 12/23/2020Open, Classified |
| Z-2177-2021 Class II | Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum, SKU…Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581… | Tenderneeds Fertility LLC | 12/23/2020Open, Classified |
| Z-2176-2021 Class II | Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuiktDevice was distributed without a proper marketing authorization. This event is an expansion of RES 87581… | Tenderneeds Fertility LLC | 12/23/2020Open, Classified |
| Z-2175-2021 Class II | Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581… | Tenderneeds Fertility LLC | 12/23/2020Open, Classified |
| Z-1364-2021 Class II | Professional At Home Artificial Intrauterine Insemination Set (SKU 644042787811)Device was distributed without a proper marketing authorization. | Tenderneeds Fertility LLC | 12/23/2020Open, Classified |
| Z-1363-2021 Class II | Pro Series Fertility Device (SKU 644042788139)Device was distributed without a proper marketing authorization. | Tenderneeds Fertility LLC | 12/23/2020Open, Classified |
| Z-1362-2021 Class II | Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962…Device was distributed without a proper marketing authorization. | Tenderneeds Fertility LLC | 12/23/2020Open, Classified |
| Z-1361-2021 Class II | Professional Artificial Intrauterine Insemination Kit (SKU 636391205986)Device was distributed without a proper marketing authorization. | Tenderneeds Fertility LLC | 12/23/2020Open, Classified |
| Z-1360-2021 Class II | Premium At Home Pro Series Insemination Kit (SKU 644042787927)Device was distributed without a proper marketing authorization. | Tenderneeds Fertility LLC | 12/23/2020Open, Classified |
| Z-1359-2021 Class II | Deluxe At Home Artificial Insemination Kit (SKU 636391205832)Device was distributed without a proper marketing authorization. | Tenderneeds Fertility LLC | 12/23/2020Open, Classified |
| Z-1358-2021 Class II | Deluxe At Home Pro Series Insemination Kit (SKU 644042787958)Device was distributed without a proper marketing authorization. | Tenderneeds Fertility LLC | 12/23/2020Open, Classified |
| Z-1357-2021 Class II | At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870)Device was distributed without a proper marketing authorization. | Tenderneeds Fertility LLC | 12/23/2020Open, Classified |
| Z-1356-2021 Class II | At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903)Device was distributed without a proper marketing authorization. | Tenderneeds Fertility LLC | 12/23/2020Open, Classified |
| Z-1355-2021 Class II | At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894…Device was distributed without a proper marketing authorization. | Tenderneeds Fertility LLC | 12/23/2020Open, Classified |
| Z-0416-2020 Class II | Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the…Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the… | Cook Inc. | 10/03/2019Terminated |
| Z-0415-2020 Class II | Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into…Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the… | Cook Inc. | 10/03/2019Terminated |
| Z-1188-2018 Class II | 1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Number:…Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device… | Cook Inc. | 12/19/2017Terminated |
| Z-1187-2018 Class II | Marrs Laparoscopic GIFT Catheters, Catalog Number:K-J-MLC-503000, Global Product Number:…Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device… | Cook Inc. | 12/19/2017Terminated |
| Z-1186-2018 Class II | Echosight Jansen-Anderson Intratubal Transfer Set, Catalog Number: K-J-JITS-572900…Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device… | Cook Inc. | 12/19/2017Terminated |
| Z-1244-2013 Class II | Wallace Sure-Pro Single Stage Embryo Replacement Catheter Product Code: PP623 Sure-Pro…Unable to pass catheter through outer sheath during embryo transfer | Smiths Medical ASD, Inc. | 03/28/2013Terminated |
| Z-1243-2013 Class II | Wallace Sure-Pro Two Stage Embryo Replacement Catheter for difficult transfer with…Unable to pass catheter through outer sheath during embryo transfer | Smiths Medical ASD, Inc. | 03/28/2013Terminated |
| Z-1242-2013 Class II | Wallace Sure-Pro Two Stage Embryo Replacement Catheter with Obturator PPB623 Sure-Pro…Unable to pass catheter through outer sheath during embryo transfer | Smiths Medical ASD, Inc. | 03/28/2013Terminated |
| Z-1241-2013 Class II | Wallace Sure-Pro Ultra Embryo Replacement Catheter with Stylet Product Code:PES623…Unable to pass catheter through outer sheath during embryo transfer | Smiths Medical ASD, Inc. | 03/28/2013Terminated |
| Z-1240-2013 Class II | Wallace Sure-Pro Ultra Embryo Replacement Catheter with Obturator Product Code: PEB623…Unable to pass catheter through outer sheath during embryo transfer | Smiths Medical ASD, Inc. | 03/28/2013Terminated |
| Z-1239-2013 Class II | Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with ultrasound) Product…Unable to pass catheter through outer sheath during embryo transfer | Smiths Medical ASD, Inc. | 03/28/2013Terminated |
| Z-0667-2008 | Morton IUI Catheter, Sterile, Single Use Only, Order #: ftr510, Manufactured by…Expiration Date for sterility; The 5 year dating could not be validated/supported for sterility assurance. | Fertility Technology Resources, Inc. | 09/13/2007Terminated |
| Z-0666-2008 | Tucker Embryo Catheter for Trial Transfer, 20 cm, Order #: ftr320, Manufactured by:…Expiration Date for sterility; The 5 year dating could not be validated/supported for sterility assurance. | Fertility Technology Resources, Inc. | 09/13/2007Terminated |
| Z-0665-2008 | Tucker Embryo Catheter with URM Tip, Embryo Transfer Catheter, 23 cm, Order #: ftr123…Expiration Date for sterility; The 5 year dating could not be validated/supported for sterility assurance. | Fertility Technology Resources, Inc. | 09/13/2007Terminated |
| Z-0664-2008 | Tucker Embryo Catheter with URM Tip, Embryo Transfer Catheter, 20 cm, Order #: ftr120…Expiration Date for sterility; The 5 year dating could not be validated/supported for sterility assurance. | Fertility Technology Resources, Inc. | 09/13/2007Terminated |
| Z-0663-2008 | Tucker Embryo Catheter, Stylet, For use with Embryo Transfer Catheter, 20 cm, Sterile…Expiration Date for sterility; The 5 year dating could not be validated/supported for sterility assurance. | Fertility Technology Resources, Inc. | 09/13/2007Terminated |
| Z-0662-2008 | Tucker Embryo Catheter, Stylet, For use with Embryo Transfer Catheter, 23 CM, Sterile…Expiration Date for Sterility; The 5 year dating could not be validated/supported for sterility assurance. | Fertility Technology Resources, Inc. | 09/13/2007Terminated |