Product code MQE

Device name: Needle, Assisted Reproduction
Medical specialty: Obstetrics/Gynecology
Device class: 2
Regulation number: 884.6100
Review panel: OB
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K240523	VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)	Shenzhen Vitavitro Biotech Co., Ltd.	2024-11-15
K232163	Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle	Zhejiang Horizon Medical Technology Co., Ltd.	2024-02-22
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.	2019-11-25
K191291	Wallace Dual Lumen Oocyte Recovery System	CooperSurgical, Inc.	2019-06-12
K182959	Wallace Dual Lumen Oocyte Recovery System	CooperSurgical, Inc.	2019-05-10
K171625	Single Lumen Ovum Aspiration Needles	Willian A. Cook Australia Pty, Ltd.	2018-01-12
K171611	Double Lumen Ovum Aspiration Needles	William A. Cook Australia Pty. , Ltd.	2017-12-15
K172050	Follicle Aspiration Set, Reduced Single Lumen	Vitrolife Sweden AB	2017-11-21
K162881	Kitazato OPU Needles	Kitazato Corporation	2017-07-11
K161970	Follicle Aspiration Set	Vitrolife Sweden AB	2017-06-14
K141365	OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN	William A. Cook Australia Pty. , Ltd.	2014-08-07
K112462	KITAZATO OPU NEEDLE	Kitazato Medical Co., Ltd.	2012-11-26
K082727	FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN	Vitrolife Sweden AB	2009-02-06
K051742	OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH	Inntec, Inc.	2005-10-07
K032208	MONA LISA ASPIRATION NEEDLE	Fertility Technology Resources, Inc.	2003-12-09
K032015	EMBRYON ULTRASOUND NEEDLE GUIDE	Rocket Medical Plc	2003-08-08
K031622	WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS	Portex , Ltd.	2003-06-26
K023930	COOPERSURGICAL OOCYTE RECOVERY NEEDLES	CooperSurgical, Inc.	2003-01-22
K013497	FAS SET #4551	Gynetics Medical Products NV	2001-11-09
K012068	WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S	Sims Portex , Ltd.	2001-08-03
K003056	OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218	Labotect Labor-Technik Gottingen	2000-12-13
K000205	EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES	Rocket Medical Plc	2000-04-19
K000628	WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733	Sims Portex , Ltd.	2000-03-13
K991271	OOCYTE ASPIRATION NEEDLE	Casmed UK	2000-03-08
K994417	OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING	Cook Urological, Inc.	2000-03-01
K992308	OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138	Lifetek Medical, Inc.	1999-09-13
K991020	DOUBLE LUMEN NEEDLE	Intl., Inc.	1999-09-09
K991262	SINGLE LUMEN NEEDLE	Intl., Inc.	1999-09-09
K991264	SINGLE LUMEN SIDEPORT NEEDLE	Intl., Inc.	1999-09-09
K991273	SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE	Swemed Lab International AB	1999-08-18

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
10841436122211	Needle Guide	CIVCO MEDICAL INSTRUMENTS CO., INC.	2024-06-20
10841436123249	Needle Guide	CIVCO MEDICAL INSTRUMENTS CO., INC.	2024-06-20
10841436123225	Needle Guide	CIVCO MEDICAL INSTRUMENTS CO., INC.	2024-06-20
10841436122365	Needle Guide	CIVCO MEDICAL INSTRUMENTS CO., INC.	2024-06-20
10841436122358	Needle Guide	CIVCO MEDICAL INSTRUMENTS CO., INC.	2024-06-20
10841436122334	Needle Guide	CIVCO MEDICAL INSTRUMENTS CO., INC.	2024-06-20
10841436122310	Needle Guide	CIVCO MEDICAL INSTRUMENTS CO., INC.	2024-06-20
10841436122297	Needle Guide	CIVCO MEDICAL INSTRUMENTS CO., INC.	2024-06-20
10841436122273	Needle Guide	CIVCO MEDICAL INSTRUMENTS CO., INC.	2024-06-20
10841436122266	Needle Guide	CIVCO MEDICAL INSTRUMENTS CO., INC.	2024-06-20
10841436122242	Needle Guide	CIVCO MEDICAL INSTRUMENTS CO., INC.	2024-06-20
10841436122228	Needle Guide	CIVCO MEDICAL INSTRUMENTS CO., INC.	2024-06-20
15019315016707	Wallace	ICU MEDICAL, INC.	2017-01-03
15019315059278	Wallace	ICU MEDICAL, INC.	2017-01-03
15019315059261	Wallace	ICU MEDICAL, INC.	2017-01-03
15019315059254	Wallace	ICU MEDICAL, INC.	2017-01-03
15019315047060	Wallace	ICU MEDICAL, INC.	2017-01-03
15019315047053	Wallace	ICU MEDICAL, INC.	2017-01-03
15019315016653	Wallace	ICU MEDICAL, INC.	2017-01-03
15019315016646	Wallace	ICU MEDICAL, INC.	2017-01-03
15019315016844	Wallace	ICU MEDICAL, INC.	2016-10-05
15019315016851	Wallace	ICU MEDICAL, INC.	2016-10-05
15019315017391	Wallace	ICU MEDICAL, INC.	2016-10-05
15019315016752	Wallace	ICU MEDICAL, INC.	2016-10-05
15019315016745	Wallace	ICU MEDICAL, INC.	2016-10-05
15019315059285	Wallace	ICU MEDICAL, INC.	2016-10-05
15019315059292	Wallace	ICU MEDICAL, INC.	2016-10-05
15019315059308	Wallace	ICU MEDICAL, INC.	2016-10-05
15019315059315	Wallace	ICU MEDICAL, INC.	2016-10-05
00827002341746	Cook	WILLIAM A. COOK AUSTRALIA PTY. LTD.	2016-09-24

Product code MQE

Related 510(k) Records#

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