FDA Product Code
FDA Product Code MQK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.6160
510(k) Clearances — 50 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K241626 | SperSort Sperm Sorting Chip (IPG02) | Ipreg Incorporation | 2025-02-20 | Traditional | PDF ↗ |
| K241454 | Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) | Guangzhou Hehong Biotech Co., Ltd. | 2025-02-03 | Traditional | PDF ↗ |
| K241348 | SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) | Motilitycount Aps | 2025-01-31 | Traditional | PDF ↗ |
| K241341 | cryo-GO Vitrification Device | Fujifilm Irvine Scientific | 2024-09-26 | Traditional | PDF ↗ |
| K240002 | G-Vitri Vitrification Straw | Gimbo Medical Technology Shenzhen Co., Ltd. | 2024-06-14 | Traditional | PDF ↗ |
| K232980 | SpermAlign Sperm Separation Device | Cytoswim, Ltd. | 2024-03-14 | Traditional | PDF ↗ |
| K233177 | Nest VT Vitrification Device | Cook Incorporated | 2024-03-08 | Traditional | PDF ↗ |
| K221810 | LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device | Bonraybio Co., Ltd. | 2022-10-31 | Traditional | PDF ↗ |
| K213869 | EmbryoSlide+ ic8 dish | Vitrolife A/S | 2022-03-11 | Traditional | PDF ↗ |
| K203626 | SureStrip Vitrification Straw, SureLock Vitrification Straw | Allwin Medical Devices, Inc. | 2021-06-04 | Traditional | PDF ↗ |
| K201213 | Pasteur Pipette 3mL, Pasteur Pipette 1mL | Hertart Aps | 2020-12-16 | Traditional | PDF ↗ |
| K200815 | VitriGuard | Origio A/S | 2020-06-25 | Traditional | PDF ↗ |
| K181461 | Rapid-i Kit | Vitrolife Sweden AB | 2019-01-04 | Traditional | PDF ↗ |
| K181469 | Cryotop®US-flash and Cryotop®US-scoop | Kitazato Corporation | 2018-11-09 | Traditional | PDF ↗ |
| K180740 | VitriGuard | Origio A/S | 2018-05-04 | Special | PDF ↗ |
| K173075 | ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml) | Dxnow, Inc. | 2018-03-08 | Abbreviated | PDF ↗ |
| K172751 | iVitri Straw | Reprobitech Corp. | 2018-02-09 | Traditional | PDF ↗ |
| K162640 | iVitri EZ | Reprobitech Corp. | 2017-06-30 | Traditional | PDF ↗ |
| K162833 | VitriGuard | Origio A/S | 2017-02-16 | Traditional | PDF ↗ |
| K162051 | Cryotec | Reprolife, Inc. | 2016-12-14 | Traditional | PDF ↗ |
| K153027 | Cryotop US | Kitazato Biopharma Co., Ltd. | 2016-03-14 | Traditional | PDF ↗ |
| K150961 | EmbryoSlide Culture Dish | Vitrolife A/S | 2015-12-04 | Traditional | PDF ↗ |
| K150756 | Micro well group culture dish, 9-well; Micro well group culture dish, 16-well | Hertart | 2015-07-20 | Traditional | PDF ↗ |
| K140207 | RAPID-I KIT | Vitrolife Sweden AB | 2014-12-18 | Traditional | PDF ↗ |
| K141663 | EEVA DISH (WITH 12 MICROWELLS) | Auxogyn, Inc. | 2014-07-22 | Special | PDF ↗ |
| K133295 | QUALIS | Menicon Co., Ltd. New Business Division | 2014-06-18 | Traditional | PDF ↗ |
| K140072 | CRYOTOP(R) SC | Kitazato Biopharma Co., Ltd. | 2014-04-03 | Traditional | PDF ↗ |
| K131145 | PROINSERT | Nidacon International AB | 2014-02-20 | Traditional | PDF ↗ |
| K122982 | CRYOLOCK | Biotech, Inc. | 2014-01-09 | Traditional | PDF ↗ |
| K123641 | CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH | Hertart | 2013-07-03 | Traditional | PDF ↗ |
| K112644 | SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM | Lotus Bio, Ltd. | 2012-12-19 | Traditional | PDF ↗ |
| K112695 | CRYOTOP | Kitazato Biopharma Co;Ltd | 2012-12-12 | Traditional | PDF ↗ |
| K112413 | RI MSC (MIGRATION SEDIMENTATION CHAMBER) | Research Instruments , Ltd. | 2012-07-13 | Traditional | PDF ↗ |
| K103028 | EEVATM PETRI DISH | Auxogyn, Inc. | 2011-08-11 | Traditional | PDF ↗ |
| K100596 | CRYOPETTE | Mid-Atlantic Diagnostics, Inc. | 2010-12-06 | Traditional | PDF ↗ |
| K092398 | HSV STRAW | Cryo Bio System | 2010-10-06 | Traditional | PDF ↗ |
| K090832 | RAPID-I | Vitrolife Sweden AB | 2009-12-23 | Traditional | PDF ↗ |
| K090429 | NUNC IVF CENTERWELL AND ICSI DISHES | Thermo Fisher Scientific (Nalge Nunc Intl) | 2009-09-18 | Traditional | PDF ↗ |
| K081896 | BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH | Biogenics, Inc. | 2008-08-20 | Traditional | PDF ↗ |
| K080395 | SUNIVF DISHES | <Genx> Intl., Inc. | 2008-08-13 | Traditional | PDF ↗ |
| K070047 | NUNC IVF DISHES AND NUNC IVF 4-WELL DISH | Nunc A/S | 2007-05-18 | Traditional | PDF ↗ |
| K052457 | PICSI SPERM SELECTION DEVICE | Biocoat, Inc. | 2006-04-13 | Traditional | PDF ↗ |
| K040717 | NUNC IVF MULTIDISH 4 WELLS NUNCLON | Nunc A/S | 2004-08-12 | Traditional | PDF ↗ |
| K000915 | PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75 | Humagen Fertility Diagnostics, Inc. | 2000-05-12 | Traditional | PDF ↗ |
| K994361 | ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL | Genesis Industries, Inc. | 2000-02-18 | Traditional | PDF ↗ |
| K993881 | GENX CULTURE DISH | <Genx> Intl., Inc. | 2000-02-14 | Traditional | PDF ↗ |
| K990941 | NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L | Humagen Fertility Diagnostics, Inc. | 1999-07-14 | Traditional | PDF ↗ |
| K991249 | FALCON IVF FOUR WELL PLATE | Becton Dickinson Labware | 1999-05-05 | Traditional | PDF ↗ |
| K991253 | FALCON IVF ROUND DISH | Becton Dickinson Labware | 1999-05-05 | Traditional | PDF ↗ |
| K991251 | FALCON IVF ONE WELL DISH | Becton Dickinson Labware | 1999-05-05 | Traditional | PDF ↗ |
Product code MQK · Class II · Obstetrics/Gynecology. Data: openFDA.