Atlas FDA

MQE

33 FDA 510(k) clearances · Product code

138 daysmedian time to decision
270 days90th percentile
33clearances measured

FDA profile

Official device name
Needle, Assisted Reproduction
Device class
Class II (moderate risk)
Regulation
21 CFR 884.6100
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
Adverse events (MAUDE)
2016: 18 · 2023: 37 · 2024: 20 · 2025: 37 · 2026: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle (K253121)Gimbo Medical Technology Shenzhen Co., Ltd.2026-06-15
VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) (K240523)Shenzhen Vitavitro Biotech Co., Ltd.2024-11-15
Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle (K232163)Zhejiang Horizon Medical Technology Co., Ltd.2024-02-22
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.2019-11-25
Wallace Dual Lumen Oocyte Recovery System (K191291)CooperSurgical, Inc.2019-06-12
Wallace Dual Lumen Oocyte Recovery System (K182959)CooperSurgical, Inc.2019-05-10
Single Lumen Ovum Aspiration Needles (K171625)Willian A. Cook Australia Pty, Ltd.2018-01-12
Double Lumen Ovum Aspiration Needles (K171611)William A. Cook Australia Pty. , Ltd.2017-12-15
Follicle Aspiration Set, Reduced Single Lumen (K172050)Vitrolife Sweden AB2017-11-21
Kitazato OPU Needles (K162881)Kitazato Corporation2017-07-11
Follicle Aspiration Set (K161970)Vitrolife Sweden AB2017-06-14
OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN (K141365)William A. Cook Australia Pty. , Ltd.2014-08-07
KITAZATO OPU NEEDLE (K112462)Kitazato Medical Co., Ltd.2012-11-26
FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN (K082727)Vitrolife Sweden AB2009-02-06
OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH (K051742)Inntec, Inc.2005-10-07
MONA LISA ASPIRATION NEEDLE (K032208)Fertility Technology Resources, Inc.2003-12-09
EMBRYON ULTRASOUND NEEDLE GUIDE (K032015)Rocket Medical Plc2003-08-08
WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS (K031622)Portex , Ltd.2003-06-26
COOPERSURGICAL OOCYTE RECOVERY NEEDLES (K023930)CooperSurgical, Inc.2003-01-22
FAS SET #4551 (K013497)Gynetics Medical Products NV2001-11-09
WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S (K012068)Sims Portex , Ltd.2001-08-03
OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218 (K003056)Labotect Labor-Technik Gottingen2000-12-13
EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES (K000205)Rocket Medical Plc2000-04-19
WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733 (K000628)Sims Portex , Ltd.2000-03-13
OOCYTE ASPIRATION NEEDLE (K991271)Casmed UK2000-03-08
OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING (K994417)Cook Urological, Inc.2000-03-01
OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138 (K992308)Lifetek Medical, Inc.1999-09-13
<GEN>SINGLE LUMEN NEEDLE (K991262)<Genx> Intl., Inc.1999-09-09
<GENX> SINGLE LUMEN SIDEPORT NEEDLE (K991264)<Genx> Intl., Inc.1999-09-09
<GENX> DOUBLE LUMEN NEEDLE (K991020)<Genx> Intl., Inc.1999-09-09
SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE (K991273)Swemed Lab International AB1999-08-18
HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU (K990913)Laboratoires Prodimed1999-06-08
OVUM PICK-UP ASPIRATION NEEDLES (K983593)Cook Ob/Gyn1999-01-21

Track MQE automatically

Every clearance here is in the API, with alerts when new ones post.