Needle, Assisted Reproduction

FDA product code MQE · 32 cleared devices

Class 2 Obstetrics/Gynecology

Regulation: 21 CFR 884.6100
Review panel: OB
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1999-01-21 – 2026-06-15

MQE 2026-06-15

Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle

Applicant Gimbo Medical Technology Shenzhen Co., Ltd.

K number K253121

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MQE 2024-11-15

VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)

Applicant Shenzhen Vitavitro Biotech Co., Ltd.

K number K240523

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MQE 2024-02-22

Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle

Applicant Zhejiang Horizon Medical Technology Co., Ltd.

K number K232163

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MQE 2019-11-25

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)

Applicant Allwin Medical Devices, Inc.

K number K190590

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MQE 2019-06-12

Wallace Dual Lumen Oocyte Recovery System

Applicant CooperSurgical, Inc.

K number K191291

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MQE 2019-05-10

Wallace Dual Lumen Oocyte Recovery System

Applicant CooperSurgical, Inc.

K number K182959

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MQE 2018-01-12

Single Lumen Ovum Aspiration Needles

Applicant Willian A. Cook Australia Pty, Ltd.

K number K171625

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MQE 2017-12-15

Double Lumen Ovum Aspiration Needles

Applicant William A. Cook Australia Pty. , Ltd.

K number K171611

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MQE 2017-11-21

Follicle Aspiration Set, Reduced Single Lumen

Applicant Vitrolife Sweden AB

K number K172050

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MQE 2017-07-11

Kitazato OPU Needles

Applicant Kitazato Corporation

K number K162881

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MQE 2017-06-14

Follicle Aspiration Set

Applicant Vitrolife Sweden AB

K number K161970

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MQE 2012-11-26

KITAZATO OPU NEEDLE

Applicant Kitazato Medical Co., Ltd.

K number K112462

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MQE 2009-02-06

FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN

Applicant Vitrolife Sweden AB

K number K082727

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MQE 2005-10-07

OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH

Applicant Inntec, Inc.

K number K051742

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MQE 2003-12-09

MONA LISA ASPIRATION NEEDLE

Applicant Fertility Technology Resources, Inc.

K number K032208

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MQE 2003-08-08

EMBRYON ULTRASOUND NEEDLE GUIDE

Applicant Rocket Medical Plc

K number K032015

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MQE 2003-06-26

WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS

Applicant Portex , Ltd.

K number K031622

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MQE 2003-01-22

COOPERSURGICAL OOCYTE RECOVERY NEEDLES

Applicant CooperSurgical, Inc.

K number K023930

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MQE 2001-11-09

FAS SET #4551

Applicant Gynetics Medical Products NV

K number K013497

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MQE 2001-08-03

WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S

Applicant Sims Portex , Ltd.

K number K012068

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MQE 2000-12-13

OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218

Applicant Labotect Labor-Technik Gottingen

K number K003056

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MQE 2000-04-19

EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES

Applicant Rocket Medical Plc

K number K000205

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MQE 2000-03-13

WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733

Applicant Sims Portex , Ltd.

K number K000628

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MQE 2000-03-08

OOCYTE ASPIRATION NEEDLE

Applicant Casmed UK

K number K991271

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MQE 2000-03-01

OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING

Applicant Cook Urological, Inc.

K number K994417

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MQE 1999-09-13

OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138

Applicant Lifetek Medical, Inc.

K number K992308

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MQE 1999-09-09

<GENX> SINGLE LUMEN SIDEPORT NEEDLE

Applicant <Genx> Intl., Inc.

K number K991264

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MQE 1999-09-09

<GEN>SINGLE LUMEN NEEDLE

Applicant <Genx> Intl., Inc.

K number K991262

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MQE 1999-09-09

<GENX> DOUBLE LUMEN NEEDLE

Applicant <Genx> Intl., Inc.

K number K991020

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MQE 1999-08-18

SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE

Applicant Swemed Lab International AB

K number K991273

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MQE 1999-06-08

HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU

Applicant Laboratoires Prodimed

K number K990913

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MQE 1999-01-21

OVUM PICK-UP ASPIRATION NEEDLES

Applicant Cook Ob/Gyn

K number K983593

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