Product code MQK
- Device name
- Labware, Assisted Reproduction
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.6160
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241626 | SperSort™ Sperm Sorting Chip (IPG02) | Ipreg Incorporation | 2025-02-20 |
| 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 |
| K241348 | SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) | Motilitycount Aps | 2025-01-31 |
| K241341 | cryo-GO Vitrification Device | Fujifilm Irvine Scientific | 2024-09-26 |
| K240002 | G-Vitri™ Vitrification Straw | Gimbo Medical Technology Shenzhen Co., Ltd. | 2024-06-14 |
| K232980 | SpermAlign Sperm Separation Device | Cytoswim, Ltd. | 2024-03-14 |
| K233177 | Nest VT Vitrification Device | Cook Incorporated | 2024-03-08 |
| K221810 | LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device | Bonraybio Co., Ltd. | 2022-10-31 |
| K213869 | EmbryoSlide+ ic8 dish | Vitrolife A/S | 2022-03-11 |
| K203626 | SureStrip Vitrification Straw, SureLock Vitrification Straw | Allwin Medical Devices, Inc. | 2021-06-04 |
| K201213 | Pasteur Pipette 3mL, Pasteur Pipette 1mL | Hertart Aps | 2020-12-16 |
| K200815 | VitriGuard | Origio A/S | 2020-06-25 |
| K181461 | Rapid-i™ Kit | Vitrolife Sweden AB | 2019-01-04 |
| K181469 | Cryotop®US-flash and Cryotop®US-scoop | Kitazato Corporation | 2018-11-09 |
| K180740 | VitriGuard | Origio A/S | 2018-05-04 |
| K173075 | ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml) | Dxnow, Inc. | 2018-03-08 |
| K172751 | iVitri Straw | Reprobitech Corp. | 2018-02-09 |
| K162640 | iVitri EZ | Reprobitech Corp. | 2017-06-30 |
| K162833 | VitriGuard | Origio A/S | 2017-02-16 |
| K162051 | Cryotec | Reprolife, Inc. | 2016-12-14 |
| K153027 | Cryotop US | Kitazato Biopharma Co., Ltd. | 2016-03-14 |
| K150961 | EmbryoSlide Culture Dish | Vitrolife A/S | 2015-12-04 |
| K150756 | Micro well group culture dish, 9-well; Micro well group culture dish, 16-well | Hertart | 2015-07-20 |
| K140207 | RAPID-I KIT | Vitrolife Sweden AB | 2014-12-18 |
| K141663 | EEVA DISH (WITH 12 MICROWELLS) | Auxogyn, Inc. | 2014-07-22 |
| K133295 | QUALIS | Menicon Co., Ltd. New Business Division | 2014-06-18 |
| K140072 | CRYOTOP(R) SC | Kitazato Biopharma Co., Ltd. | 2014-04-03 |
| K131145 | PROINSERT | Nidacon International AB | 2014-02-20 |
| K122982 | CRYOLOCK | Biotech, Inc. | 2014-01-09 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B056CLRCTLG1 | CRYOLOCK(LG) | BIOTECH INCORPORATED | 2025-12-08 |
| B056CLRCTPR1 | CRYOLOCK(PR) | BIOTECH INCORPORATED | 2025-10-27 |
| B056CLRCTPK1 | CRYOLOCK(PK) | BIOTECH INCORPORATED | 2025-10-27 |
| 20888937025860 | PICSI® | Coopersurgical, Inc. | 2025-10-20 |
| 15070002516207 | SpermAlign | CYTOSWIM LTD | 2025-03-03 |
| 10860004123900 | ZyMot | DXNOW, INC. | 2021-02-25 |
| 10860451001233 | ZyMot | DXNOW, INC. | 2021-02-25 |
| 10860451001240 | ZyMot | DXNOW, INC. | 2021-02-25 |
| 10860451001257 | ZyMot | DXNOW, INC. | 2021-02-25 |
| B056SCLB1 | S-CRYOLOCK (B) | BIOTECH INCORPORATED | 2019-04-26 |
| 09348265003086 | Geri Software Connect and Assess 2.0 | GENEA BIOMEDX PTY LTD | 2018-06-19 |
| 09348265003017 | Geri Dish | GENEA BIOMEDX PTY LTD | 2017-12-08 |
| 09348265003000 | Geri Embryo Incubator | GENEA BIOMEDX PTY LTD | 2017-12-08 |
| B056CLRCTC1 | CRYOLOCK(C) | BIOTECH INCORPORATED | 2017-04-21 |
| B056CLRCTB1 | Cryolock(B) | BIOTECH INCORPORATED | 2017-04-20 |
| B056CLRCTY1 | CRYOLOCK(Y) | BIOTECH INCORPORATED | 2017-04-20 |
| B056CLRCTO1 | CRYOLOCK(O) | BIOTECH INCORPORATED | 2017-04-20 |
| B056CLRCTG1 | Cryolock(G) | BIOTECH INCORPORATED | 2017-04-20 |
| B056CLRCT1 | Cryolock | BIOTECH INCORPORATED | 2016-12-13 |
| 50888937014117 | IVF Pasteur Pipets | Coopersurgical, Inc. | 2016-09-23 |
| 50888937014124 | Cotton Plugged IVF Pasteur Pipets | Coopersurgical, Inc. | 2016-09-23 |
| 50888937014100 | Cotton Plugged IVF Pasteur Pipets | Coopersurgical, Inc. | 2016-09-23 |
| 50888937014094 | IVF Pasteur Pipets | Coopersurgical, Inc. | 2016-09-23 |
| 50888937014087 | Cotton Plugged IVF Pasteur Pipets | Coopersurgical, Inc. | 2016-09-23 |
| 50888937014070 | IVF Pasteur Pipets | Coopersurgical, Inc. | 2016-09-23 |
| 50888937014063 | Cotton Plugged IVF Pasteur Pipets | Coopersurgical, Inc. | 2016-09-23 |
| 20389151000034 | Falcon | Corning Incorporated | 2016-09-22 |
| 20389151000027 | Falcon | Corning Incorporated | 2016-09-22 |
| 20389151000010 | Falcon | Corning Incorporated | 2016-09-22 |
| 20389151000003 | Falcon | Corning Incorporated | 2016-09-22 |