FDA Product Code
FDA Product Code MQH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.6130
510(k) Clearances — 26 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250838 | Denudation Pipettes | Guangzhou Pinzhi Medical Device Co., Ltd. | 2025-07-03 | Traditional | PDF ↗ |
| K192146 | V-DENUPET | Vitromed GmbH | 2020-01-28 | Traditional | PDF ↗ |
| K161275 | EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip | Research Instruments Limited | 2017-01-23 | Traditional | PDF ↗ |
| K152581 | LifeGlobal Micro Tips | Life Global Group, LLC | 2016-04-11 | Traditional | PDF ↗ |
| K151018 | Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette | Cook Incorporated | 2016-01-08 | Traditional | PDF ↗ |
| K150748 | Flexipet Denuding Pipette, Flexipet Manipulation Pipette | Cook Incorporated | 2015-12-18 | Traditional | PDF ↗ |
| K133257 | BIOPSY PIPETTES | Research Instruments , Ltd. | 2014-05-16 | Traditional | PDF ↗ |
| K102480 | INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HA | Jieying Laboratory, Inc. | 2011-04-19 | Traditional | PDF ↗ |
| K092554 | BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES | Sunlight Medical, Inc. | 2010-04-30 | Traditional | PDF ↗ |
| K072600 | INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES | Sunlight Medical, Inc. | 2008-05-19 | Traditional | PDF ↗ |
| K041435 | THE STRIPPER PGD | Mid-Atlantic Diagnostics, Inc. | 2004-09-29 | Traditional | PDF ↗ |
| K041562 | CRYOTIP | Irvine Scientific Sales Co., Inc. | 2004-08-09 | Traditional | PDF ↗ |
| K033904 | PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES) | Cook Urological, Inc. | 2004-01-16 | Special | PDF ↗ |
| K033903 | MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, | Cook Urological, Inc. | 2004-01-16 | Special | PDF ↗ |
| K024302 | PRECISION CAPILLARIES FOR MICROMANIPULATION | Brinkmann Instruments, Inc. | 2003-02-19 | Traditional | PDF ↗ |
| K022643 | BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540 | Swemed Lab International AB | 2002-11-05 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K001615 | HUNTER SCIENTIFIC INJECTION PIPETTES | Hunter Scientific Limited | 2000-08-18 | Traditional | PDF ↗ |
| K993699 | THE STRIPPER | Mid-Atlantic Diagnostics, Inc. | 2000-05-16 | Traditional | PDF ↗ |
| K991388 | ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M | Pacific Andrology, Inc. | 1999-09-13 | Traditional | PDF ↗ |
| K991261 | ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, ASSISTED HATCHING/ZONA DRILLING MICROPIPET | Research Instruments , Ltd. | 1999-08-05 | Traditional | PDF ↗ |
| K991104 | MICROTOOLS | Conception Technology, Inc. | 1999-07-19 | Traditional | PDF ↗ |
| K991700 | SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO | Swemed Lab International AB | 1999-07-19 | Traditional | PDF ↗ |
| K990847 | INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M | Humagen Fertility Diagnostics, Inc. | 1999-07-14 | Traditional | PDF ↗ |
| K983713 | PRODIMED MICROINJECTION PIPETTES | Prodimed | 1999-06-08 | Traditional | PDF ↗ |
| K983596 | INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING | Cook Ob/Gyn | 1999-02-05 | Traditional | PDF ↗ |
Product code MQH · Class II · Obstetrics/Gynecology. Data: openFDA.