FDA 510(k) Applications for Medical Device Product Code "MQH"
(Microtools, Assisted Reproduction (Pipettes))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K024302 | BRINKMANN INSTRUMENTS, INC. | PRECISION CAPILLARIES FOR MICROMANIPULATION | 02/19/2003 |
| K991104 | CONCEPTION TECHNOLOGY, INC. | MICROTOOLS | 07/19/1999 |
| K151018 | COOK INCORPORATED | Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette | 01/08/2016 |
| K150748 | COOK INCORPORATED | Flexipet Denuding Pipette, Flexipet Manipulation Pipette | 12/18/2015 |
| K983596 | COOK OB/GYN | INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING | 02/05/1999 |
| K033903 | COOK UROLOGICAL, INC. | MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, | 01/16/2004 |
| K033904 | COOK UROLOGICAL, INC. | PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES) | 01/16/2004 |
| K012811 | HUMAGEN FERTILITY DIAGNOSTICS, INC. | BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B | 02/11/2002 |
| K990847 | HUMAGEN FERTILITY DIAGNOSTICS, INC. | INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M | 07/14/1999 |
| K001615 | HUNTER SCIENTIFIC LIMITED | HUNTER SCIENTIFIC INJECTION PIPETTES | 08/18/2000 |
| K041562 | IRVINE SCIENTIFIC SALES CO., INC. | CRYOTIP | 08/09/2004 |
| K102480 | JIEYING LABORATORY INC. | INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HA | 04/19/2011 |
| K152581 | LifeGlobal Group, LLC | LifeGlobal Micro Tips | 04/11/2016 |
| K993699 | MID-ATLANTIC DIAGNOSTICS, INC. | THE STRIPPER | 05/16/2000 |
| K041435 | MID-ATLANTIC DIAGNOSTICS, INC. | THE STRIPPER PGD | 09/29/2004 |
| K991388 | PACIFIC ANDROLOGY, INC. | ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M | 09/13/1999 |
| K983713 | PRODIMED | PRODIMED MICROINJECTION PIPETTES | 06/08/1999 |
| K161275 | RESEARCH INSTRUMENTS LIMITED | EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip | 01/23/2017 |
| K133257 | RESEARCH INSTRUMENTS LTD. | BIOPSY PIPETTES | 05/16/2014 |
| K991261 | RESEARCH INSTRUMENTS LTD. | ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, ASSISTED HATCHING/ZONA DRILLING MICROPIPET | 08/05/1999 |
| K092554 | SUNLIGHT MEDICAL, INC. | BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES | 04/30/2010 |
| K072600 | SUNLIGHT MEDICAL, INC. | INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES | 05/19/2008 |
| K022643 | SWEMED LAB INTERNATIONAL AB | BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540 | 11/05/2002 |
| K991700 | SWEMED LAB INTERNATIONAL AB | SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO | 07/19/1999 |
| K192146 | Vitromed GmbH | V-DENUPET | 01/28/2020 |
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