MQH — Microtools, Assisted Reproduction (Pipettes) Class II
FDA Device Classification
Classification Details
- Product Code
- MQH
- Device Class
- Class II
- Regulation Number
- 884.6130
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K250838 | guangzhou pinzhi medical device co | Denudation Pipettes | July 3, 2025 |
| K192146 | vitromed | V-DENUPET | January 28, 2020 |
| K161275 | research instruments limited | EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip | January 23, 2017 |
| K152581 | life global group | LifeGlobal Micro Tips | April 11, 2016 |
| K151018 | cook incorporated | Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pi | January 8, 2016 |
| K150748 | cook incorporated | Flexipet Denuding Pipette, Flexipet Manipulation Pipette | December 18, 2015 |
| K133257 | research instruments | BIOPSY PIPETTES | May 16, 2014 |
| K102480 | jieying laboratory | INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZO | April 19, 2011 |
| K092554 | sunlight medical | BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES | April 30, 2010 |
| K072600 | sunlight medical | INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL | May 19, 2008 |
| K041435 | mid-atlantic diagnostics | THE STRIPPER PGD | September 29, 2004 |
| K041562 | irvine scientific sales co | CRYOTIP | August 9, 2004 |
| K033904 | cook urological | PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES) | January 16, 2004 |
| K033903 | cook urological | MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTE | January 16, 2004 |
| K024302 | brinkmann instruments | PRECISION CAPILLARIES FOR MICROMANIPULATION | February 19, 2003 |
| K022643 | swemed lab international | BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540 | November 5, 2002 |
| K012811 | humagen fertility diagnostics | BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-M | February 11, 2002 |
| K001615 | hunter scientific limited | HUNTER SCIENTIFIC INJECTION PIPETTES | August 18, 2000 |
| K993699 | mid-atlantic diagnostics | THE STRIPPER | May 16, 2000 |
| K991388 | pacific andrology | ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI | September 13, 1999 |