MQE · Class II · 21 CFR 884.6100

FDA Product Code MQE: Needle, Assisted Reproduction

Leading manufacturers include CooperSurgical, Inc., Vitrolife Sweden AB and Willian A. Cook Australia Pty, Ltd..

33
Total
33
Cleared
149d
Avg days
1999
Since
Growing category - 2 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 265d recently vs 141d historically

FDA 510(k) Cleared Needle, Assisted Reproduction Devices (Product Code MQE)

33 devices
1–24 of 33
Cleared Nov 15, 2024
VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)
K240523
Shenzhen Vitavitro Biotech Co., Ltd.
Obstetrics & Gynecology · 266d
Cleared Feb 22, 2024
Lotus Single Lumen Ovum Aspiration Needle
K232163
Zhejiang Horizon Medical Technology Co., Ltd.
Obstetrics & Gynecology · 216d
Cleared Nov 25, 2019
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)
K190590
Allwin Medical Devices, Inc.
Obstetrics & Gynecology · 263d
Cleared Jun 12, 2019
Wallace Dual Lumen Oocyte Recovery System
K191291
CooperSurgical, Inc.
Obstetrics & Gynecology · 29d
Cleared May 10, 2019
Wallace Dual Lumen Oocyte Recovery System
K182959
CooperSurgical, Inc.
Obstetrics & Gynecology · 197d
Cleared Jan 12, 2018
Single Lumen Ovum Aspiration Needles
K171625
Willian A. Cook Australia Pty, Ltd.
Obstetrics & Gynecology · 224d
Cleared Nov 21, 2017
Follicle Aspiration Set, Reduced Single Lumen
K172050
Vitrolife Sweden AB
Obstetrics & Gynecology · 138d
Cleared Jun 14, 2017
Follicle Aspiration Set
K161970
Vitrolife Sweden AB
Obstetrics & Gynecology · 331d
Cleared Feb 06, 2009
FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN
K082727
Vitrolife Sweden AB
Obstetrics & Gynecology · 142d
Cleared Jan 22, 2003
COOPERSURGICAL OOCYTE RECOVERY NEEDLES
K023930
CooperSurgical, Inc.
Obstetrics & Gynecology · 58d
Cleared Mar 01, 2000
OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING
K994417
Cook Urological, Inc.
Obstetrics & Gynecology · 63d
Cleared Jan 21, 1999
OVUM PICK-UP ASPIRATION NEEDLES
K983593
Cook Ob/Gyn
Obstetrics & Gynecology · 100d

About Product Code MQE - Regulatory Context

510(k) Submission Activity

33 total 510(k) submissions under product code MQE since 1999, with 33 receiving FDA clearance (average review time: 149 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - MQE Product Code

Recent submissions under MQE have taken an average of 265 days to reach a decision - up from 141 days historically. Manufacturers should account for longer review timelines in current project planning.

MQE devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →