MQE · Needle, Assisted Reproduction
Obstetrics/Gynecology · 21 CFR 884.6100 · Class 2
Overview
| Product Code | MQE |
|---|---|
| Device Name | Needle, Assisted Reproduction |
| Regulation | 21 CFR 884.6100 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.
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 32)
Showing 20 most recent of 32 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K240523 | VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) | Shenzhen Vitavitro Biotech Co., Ltd. | Nov 15, 2024 | SESE |
| K232163 | Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle | Zhejiang Horizon Medical Technology Co., Ltd. | Feb 22, 2024 | SESE |
| K190590 | Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle) | Allwin Medical Devices, Inc. | Nov 25, 2019 | SESE |
| K191291 | Wallace Dual Lumen Oocyte Recovery System | CooperSurgical, Inc. | Jun 12, 2019 | SESE |
| K182959 | Wallace Dual Lumen Oocyte Recovery System | CooperSurgical, Inc. | May 10, 2019 | SESE |
| K171625 | Single Lumen Ovum Aspiration Needles | Willian A. Cook Australia Pty, Ltd. | Jan 12, 2018 | SESE |
| K171611 | Double Lumen Ovum Aspiration Needles | William A. Cook Australia Pty. , Ltd. | Dec 15, 2017 | SESE |
| K172050 | Follicle Aspiration Set, Reduced Single Lumen | Vitrolife Sweden AB | Nov 21, 2017 | SESE |
| K162881 | Kitazato OPU Needles | Kitazato Corporation | Jul 11, 2017 | SESE |
| K161970 | Follicle Aspiration Set | Vitrolife Sweden AB | Jun 14, 2017 | SESE |
| K141365 | OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN | William A. Cook Australia Pty. , Ltd. | Aug 7, 2014 | SESE |
| K112462 | KITAZATO OPU NEEDLE | Kitazato Medical Co., Ltd. | Nov 26, 2012 | SESE |
| K082727 | FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN | Vitrolife Sweden AB | Feb 6, 2009 | SESE |
| K051742 | OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH | Inntec, Inc. | Oct 7, 2005 | SESE |
| K032208 | MONA LISA ASPIRATION NEEDLE | Fertility Technology Resources, Inc. | Dec 9, 2003 | SESE |
| K032015 | EMBRYON ULTRASOUND NEEDLE GUIDE | Rocket Medical Plc | Aug 8, 2003 | SESE |
| K031622 | WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS | Portex , Ltd. | Jun 26, 2003 | SESE |
| K023930 | COOPERSURGICAL OOCYTE RECOVERY NEEDLES | CooperSurgical, Inc. | Jan 22, 2003 | SESE |
| K013497 | FAS SET #4551 | Gynetics Medical Products NV | Nov 9, 2001 | SESE |
| K012068 | WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S | Sims Portex , Ltd. | Aug 3, 2001 | SESE |
Top Applicants
- <Genx> Intl., Inc. — 3 clearances
- CooperSurgical, Inc. — 3 clearances
- Vitrolife Sweden AB — 3 clearances
- Rocket Medical Plc — 2 clearances
- Sims Portex , Ltd. — 2 clearances
