Product code MQH

Device name: Microtools, Assisted Reproduction (Pipettes)
Medical specialty: Obstetrics/Gynecology
Device class: 2
Regulation number: 884.6130
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
K250838	Denudation Pipettes	Guangzhou Pinzhi Medical Device Co., Ltd.	2025-07-03
K192146	V-DENUPET	Vitromed GmbH	2020-01-28
K161275	EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip	Research Instruments Limited	2017-01-23
K152581	LifeGlobal Micro Tips	Life Global Group, LLC	2016-04-11
K151018	Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette	Cook Incorporated	2016-01-08
K150748	Flexipet Denuding Pipette, Flexipet Manipulation Pipette	Cook Incorporated	2015-12-18
K133257	BIOPSY PIPETTES	Research Instruments , Ltd.	2014-05-16
K102480	INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HA	Jieying Laboratory, Inc.	2011-04-19
K092554	BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES	Sunlight Medical, Inc.	2010-04-30
K072600	INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES	Sunlight Medical, Inc.	2008-05-19
K041435	THE STRIPPER PGD	Mid-Atlantic Diagnostics, Inc.	2004-09-29
K041562	CRYOTIP	Irvine Scientific Sales Co., Inc.	2004-08-09
K033903	MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES,	Cook Urological, Inc.	2004-01-16
K033904	PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES)	Cook Urological, Inc.	2004-01-16
K024302	PRECISION CAPILLARIES FOR MICROMANIPULATION	Brinkmann Instruments, Inc.	2003-02-19
K022643	BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540	Swemed Lab International AB	2002-11-05
K012811	BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B	Humagen Fertility Diagnostics, Inc.	2002-02-11
K001615	HUNTER SCIENTIFIC INJECTION PIPETTES	Hunter Scientific Limited	2000-08-18
K993699	THE STRIPPER	Mid-Atlantic Diagnostics, Inc.	2000-05-16
K991388	ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M	Pacific Andrology, Inc.	1999-09-13
K991261	ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, ASSISTED HATCHING/ZONA DRILLING MICROPIPET	Research Instruments , Ltd.	1999-08-05
K991104	MICROTOOLS	Conception Technology, Inc.	1999-07-19
K991700	SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO	Swemed Lab International AB	1999-07-19
K990847	INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M	Humagen Fertility Diagnostics, Inc.	1999-07-14
K983713	PRODIMED MICROINJECTION PIPETTES	Prodimed	1999-06-08
K983596	INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING	Cook Ob/Gyn	1999-02-05

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
10805360016442	Biopsy Pipette	VITROLIFE INC.	2020-07-13
10805360019337	ICSI Pipette	VITROLIFE INC.	2020-04-28
10805360019320	ICSI Pipette	VITROLIFE INC.	2020-04-28
10805360019313	ICSI Pipette	VITROLIFE INC.	2020-04-28
10805360019290	ICSI Pipette	VITROLIFE INC.	2020-04-28
10805360019283	ICSI Pipette	VITROLIFE INC.	2020-04-28
15019315077234	Wallace	ICU MEDICAL, INC.	2016-10-19
15019315077227	Wallace	ICU MEDICAL, INC.	2016-10-19
15019315077210	Wallace	ICU MEDICAL, INC.	2016-10-19
15019315077203	Wallace	ICU MEDICAL, INC.	2016-10-19
10805360017753	ICSI Pipette	VITROLIFE INC.	2016-09-23
10805360016084	ICSI Pipette	VITROLIFE INC.	2016-09-23
10805360016886	ICSI Pipette	VITROLIFE INC.	2016-09-23
10805360016954	ICSI Pipette	VITROLIFE INC.	2016-09-23
10805360016992	ICSI Pipette	VITROLIFE INC.	2016-09-23
10805360017463	ICSI Pipette	VITROLIFE INC.	2016-09-23
10805360017494	ICSI Pipette	VITROLIFE INC.	2016-09-23
10805360017661	ICSI Pipette	VITROLIFE INC.	2016-09-23
10805360019306	ICSI Pipette	VITROLIFE INC.	2016-09-23
10805360017685	ICSI Pipette	VITROLIFE INC.	2016-09-23
10805360017777	ICSI Pipette	VITROLIFE INC.	2016-09-23
10805360018989	ICSI Pipette	VITROLIFE INC.	2016-09-23
10805360018798	ICSI Pipette	VITROLIFE INC.	2016-09-23
10805360018552	ICSI Pipette	VITROLIFE INC.	2016-09-23
10805360017951	ICSI Pipette	VITROLIFE INC.	2016-09-23
10805360017937	ICSI Pipette	VITROLIFE INC.	2016-09-23
10805360017890	ICSI Pipette	VITROLIFE INC.	2016-09-23
10805360017869	ICSI Pipette	VITROLIFE INC.	2016-09-23
10805360017852	ICSI Pipette	VITROLIFE INC.	2016-09-23
10805360017845	ICSI Pipette	VITROLIFE INC.	2016-09-23

Product code MQH

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