Microtools, Assisted Reproduction (Pipettes)

FDA product code MQH · 24 cleared devices

Class 2 Obstetrics/Gynecology

Regulation: 21 CFR 884.6130
Review panel: OB
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1999-02-05 – 2025-07-03

MQH 2025-07-03

Denudation Pipettes

Applicant Guangzhou Pinzhi Medical Device Co., Ltd.

K number K250838

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MQH 2020-01-28

V-DENUPET

Applicant Vitromed GmbH

K number K192146

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MQH 2017-01-23

EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip

Applicant Research Instruments Limited

K number K161275

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MQH 2016-04-11

LifeGlobal Micro Tips

Applicant Life Global Group, LLC

K number K152581

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MQH 2016-01-08

Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette

Applicant Cook Incorporated

K number K151018

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MQH 2011-04-19

INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HA

Applicant Jieying Laboratory, Inc.

K number K102480

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MQH 2010-04-30

BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES

Applicant Sunlight Medical, Inc.

K number K092554

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MQH 2008-05-19

INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES

Applicant Sunlight Medical, Inc.

K number K072600

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MQH 2004-09-29

THE STRIPPER PGD

Applicant Mid-Atlantic Diagnostics, Inc.

K number K041435

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MQH 2004-08-09

CRYOTIP

Applicant Irvine Scientific Sales Co., Inc.

K number K041562

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MQH 2004-01-16

PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES)

Applicant Cook Urological, Inc.

K number K033904

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MQH 2004-01-16

MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES,

Applicant Cook Urological, Inc.

K number K033903

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MQH 2003-02-19

PRECISION CAPILLARIES FOR MICROMANIPULATION

Applicant Brinkmann Instruments, Inc.

K number K024302

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MQH 2002-11-05

BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540

Applicant Swemed Lab International AB

K number K022643

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MQH 2002-02-11

BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B

Applicant Humagen Fertility Diagnostics, Inc.

K number K012811

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MQH 2000-08-18

HUNTER SCIENTIFIC INJECTION PIPETTES

Applicant Hunter Scientific Limited

K number K001615

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MQH 2000-05-16

THE STRIPPER

Applicant Mid-Atlantic Diagnostics, Inc.

K number K993699

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MQH 1999-09-13

ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M

Applicant Pacific Andrology, Inc.

K number K991388

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MQH 1999-08-05

ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, ASSISTED HATCHING/ZONA DRILLING MICROPIPET

Applicant Research Instruments , Ltd.

K number K991261

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MQH 1999-07-19

SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO

Applicant Swemed Lab International AB

K number K991700

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MQH 1999-07-19

MICROTOOLS

Applicant Conception Technology, Inc.

K number K991104

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MQH 1999-07-14

INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M

Applicant Humagen Fertility Diagnostics, Inc.

K number K990847

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MQH 1999-06-08

PRODIMED MICROINJECTION PIPETTES

Applicant Prodimed

K number K983713

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MQH 1999-02-05

INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING

Applicant Cook Ob/Gyn

K number K983596

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