FDA.reportPublic FDA data

510(k) K240523

Device
VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)
Applicant
Shenzhen Vitavitro Biotech Co., Ltd.
510(k) number
K240523
Product code
MQE
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-15
Date received
2024-02-23
Regulation
884.6100
Classification name
Needle, Assisted Reproduction
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Donghai Pan
Address
R601, Bldg. B, Hai Ke Xing Tech Park, Baoshan Rd. #16, Shenzhen CN 518118 518118

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MQE#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K232163Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration NeedleZhejiang Horizon Medical Technology Co., Ltd.2024-02-22
K190590Allwin 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.2019-11-25
K191291Wallace Dual Lumen Oocyte Recovery SystemCooperSurgical, Inc.2019-06-12
K182959Wallace Dual Lumen Oocyte Recovery SystemCooperSurgical, Inc.2019-05-10
K171625Single Lumen Ovum Aspiration NeedlesWillian A. Cook Australia Pty, Ltd.2018-01-12
K171611Double Lumen Ovum Aspiration NeedlesWilliam A. Cook Australia Pty. , Ltd.2017-12-15
K172050Follicle Aspiration Set, Reduced Single LumenVitrolife Sweden AB2017-11-21
K162881Kitazato OPU NeedlesKitazato Corporation2017-07-11
K161970Follicle Aspiration SetVitrolife Sweden AB2017-06-14
K141365OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMENWilliam A. Cook Australia Pty. , Ltd.2014-08-07
K112462KITAZATO OPU NEEDLEKitazato Medical Co., Ltd.2012-11-26
K082727FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMENVitrolife Sweden AB2009-02-06
K051742OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SHInntec, Inc.2005-10-07
K032208MONA LISA ASPIRATION NEEDLEFertility Technology Resources, Inc.2003-12-09
K032015EMBRYON ULTRASOUND NEEDLE GUIDERocket Medical Plc2003-08-08