MQF · Catheter, Assisted Reproduction
Obstetrics/Gynecology · 21 CFR 884.6110 · Class 2
Overview
| Product Code | MQF |
|---|---|
| Device Name | Catheter, Assisted Reproduction |
| Regulation | 21 CFR 884.6110 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.
Classification Rationale
Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).
Special Controls
*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).
Recent Cleared Devices (20 of 53)
Showing 20 most recent of 53 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253354 | Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) | Guangzhou Hehong Biotech Co., Ltd. | Feb 12, 2026 | SESE |
| 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 | Jul 23, 2025 | SESE |
| K240307 | VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) | Shenzhen Vitavitro Biotech Co., Ltd. | Aug 16, 2024 | SESE |
| K231730 | FemaSeed Intratubal Insemination | Femasys, Inc. | Sep 22, 2023 | SESE |
| K220010 | Daylily Single Use Sterile Embryo Transfer Catheter | Shanghai Horizon Medical Technology Co., Ltd. | Dec 16, 2022 | SESE |
| K200248 | Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators | Allwin Medical Devices, Inc. | Jul 1, 2020 | SESE |
| K192540 | Kitazato ET Catheters | Kitazato Corporation | May 1, 2020 | SESE |
| 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. | Nov 14, 2019 | SESE |
| 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 | May 17, 2019 | SESE |
| K180302 | Guardia Access Malleable Obturator, Guardia Obturator, Soft-Pass Obturator, Soft-Trans Malleable Obturator, Guardia ETS Embryo-Tested Syringe, Flushing Catheter | Cook Incorporated | Oct 24, 2018 | SESE |
| K173431 | Towako Transmyometrial Embryo Transfer Set | William A. Cook Australia Pty. , Ltd. | May 18, 2018 | SESE |
| K173103 | Pivet and Soft-Pass Embryo Transfer Catheter Sets | Cook Incorporated | Apr 13, 2018 | SESE |
| K173686 | Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter | Cook Incorporated | Apr 11, 2018 | SESE |
| K172051 | Guardia Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter | Cook Incorporated | Jan 10, 2018 | SESE |
| K172321 | Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters | Cook Incorporated | Dec 21, 2017 | SESE |
| K163318 | Soules Intrauterine Insemination Catheter | Cook Incorporated | Jul 14, 2017 | SESE |
| K162878 | Kitazato ET Catheters | Kitazato Corporation | Jul 13, 2017 | SESE |
| K162667 | Kitazato IUI Catheter | Kitazato Corporation | May 11, 2017 | SESE |
| K161547 | Transem and EchoGen Embryo Transfer Catheters | Origio A/S | Mar 9, 2017 | SESE |
| K162064 | CrossBay IVF Embryo Transfer Catheter Set | Crossbay Medical, Inc. | Jan 5, 2017 | SESE |
Top Applicants
- Cook Incorporated — 7 clearances
- Cook Ob/Gyn — 5 clearances
- Cooper Surgical — 4 clearances
- CooperSurgical, Inc. — 3 clearances
- Fertility Technology Resources, Inc. — 3 clearances
