Product Code: MQH
FDA class 2
21 CFR 884.6130
Microtools, Assisted Reproduction (Pipettes)
Obstetrics/Gynecology
Microtools for Assisted Reproduction (Pipettes) are obstetrics/gynecology devices consisting of precision glass or polymer micropipettes used in ART procedures such as ICSI to manipulate individual oocytes, sperm, or embryos under a microscope. Classified as FDA Class 2 under 21 CFR 884.6130, they require 510(k) premarket notification. The product code is MQH, and they are eligible for third-party 510(k) review.
510(k)s
26
FEI Numbers
25
Registration Numbers
25
Unique Applicants
19
Years Active
26
Research product code MQH in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- MQH
- Device Class
- FDA class 2
- Regulation Number
- 884.6130
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
Loading...
Related 510(k) Clearances
This FDA classification is associated with 26 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250838 | Denudation Pipettes | Jul 03, 2025 | Substantially Equivalent | Guangzhou Pinzhi Medical Device Co., Ltd. |
| K192146 | V-DENUPET | Jan 28, 2020 | Substantially Equivalent | Vitromed GmbH |
| K161275 | EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip | Jan 23, 2017 | Substantially Equivalent | Research Instruments Limited |
| K152581 | LifeGlobal Micro Tips | Apr 11, 2016 | Substantially Equivalent | Life Global Group, LLC |
| K151018 | Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette | Jan 08, 2016 | Substantially Equivalent | Cook Incorporated |
| K150748 | Flexipet Denuding Pipette, Flexipet Manipulation Pipette | Dec 18, 2015 | Substantially Equivalent | Cook Incorporated |
| K133257 | BIOPSY PIPETTES | May 16, 2014 | Substantially Equivalent | Research Instruments , Ltd. |
| K102480 | INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HA | Apr 19, 2011 | Substantially Equivalent | Jieying Laboratory, Inc. |
| K092554 | BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES | Apr 30, 2010 | Substantially Equivalent | Sunlight Medical, Inc. |
| K072600 | INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES | May 19, 2008 | Substantially Equivalent | Sunlight Medical, Inc. |
| K041435 | THE STRIPPER PGD | Sep 29, 2004 | Substantially Equivalent | Mid-Atlantic Diagnostics, Inc. |
| K041562 | CRYOTIP | Aug 09, 2004 | Substantially Equivalent | Irvine Scientific Sales Co., Inc. |
| K033904 | PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES) | Jan 16, 2004 | Substantially Equivalent | Cook Urological, Inc. |
| K033903 | MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, | Jan 16, 2004 | Substantially Equivalent | Cook Urological, Inc. |
| K024302 | PRECISION CAPILLARIES FOR MICROMANIPULATION | Feb 19, 2003 | Substantially Equivalent | Brinkmann Instruments, Inc. |
| K022643 | BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540 | Nov 05, 2002 | Substantially Equivalent | Swemed Lab International AB |
| K012811 | BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B | Feb 11, 2002 | Substantially Equivalent | Humagen Fertility Diagnostics, Inc. |
| K001615 | HUNTER SCIENTIFIC INJECTION PIPETTES | Aug 18, 2000 | Substantially Equivalent | Hunter Scientific Limited |
| K993699 | THE STRIPPER | May 16, 2000 | Substantially Equivalent | Mid-Atlantic Diagnostics, Inc. |
| K991388 | ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M | Sep 13, 1999 | Substantially Equivalent | Pacific Andrology, Inc. |
| K991261 | ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, ASSISTED HATCHING/ZONA DRILLING MICROPIPET | Aug 05, 1999 | Substantially Equivalent | Research Instruments , Ltd. |
| K991700 | SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO | Jul 19, 1999 | Substantially Equivalent | Swemed Lab International AB |
| K991104 | MICROTOOLS | Jul 19, 1999 | Substantially Equivalent | Conception Technology, Inc. |
| K990847 | INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M | Jul 14, 1999 | Substantially Equivalent | Humagen Fertility Diagnostics, Inc. |
| K983713 | PRODIMED MICROINJECTION PIPETTES | Jun 08, 1999 | Substantially Equivalent | Prodimed |
| K983596 | INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING | Feb 05, 1999 | Substantially Equivalent | Cook Ob/Gyn |
FEI Numbers
This FDA classification entry is associated with 25 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 25 registration numbers. Click on an entry to view related FDA registrations.