Product code MQG
- Device name
- Accessory, Assisted Reproduction
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.6120
- 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 |
|---|---|---|---|
| K260194 | Vacuum Pump (Model: AD-VPUM-500) | Sheng Sheng Yi (Beijing) Technology Company Limited | 2026-04-28 |
| K242684 | Harioculture TL-16 Time-lapse Incubator | Hua Yue Medical Technology Co., Ltd. | 2025-05-22 |
| K232493 | Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) | Wuhan Huchuang Union Technology Co., Ltd. | 2024-05-07 |
| K180188 | Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish | Genea Biomedx Pty, Ltd. | 2018-06-07 |
| K173264 | EmbryoScope+ | Vitrolife A/S | 2018-05-11 |
| K180304 | Geri Embryo Incubator and Geri Dish | Genea Biomedx Pty, Ltd. | 2018-04-20 |
| K171736 | Geri Embryo Incubator and Geri Dish | Genea Biomedx Pty, Ltd. | 2017-11-15 |
| K160753 | COOK Vacuum Pump | William A. Cook Australia Pty. , Ltd. | 2017-06-13 |
| K160504 | RI Witness Embryology Heated Plate | Research Instruments Limited | 2016-07-18 |
| K151357 | MIRI TL | At Medical Uab | 2016-04-22 |
| K133712 | EMBRYOVIEWER SOFTWARE | Unisense Fertilitech A/S | 2014-08-08 |
| K132870 | Origio Gas Line Filter | Origio, Inc. | 2014-05-07 |
| K133742 | XQ-1 INCUBATOR | At Medical Uab | 2014-04-23 |
| K121566 | PLANER BT37 INCUBATOR | Planer Plc | 2012-11-29 |
| K113075 | EMBRYO VIEWER SOFTWARE | Unisense Fertilitech A/S | 2011-12-21 |
| K111715 | EMBRYOSCOPE | Unisense Fertilitech A/S | 2011-08-11 |
| K101988 | HEAL FORCE CO2 INCUBATOR | Shanghai Lishen Scientific Equipment Co., Ltd. | 2011-02-08 |
| K092183 | EMBRYOSCOPE AND EMBRYOSLIDE | Unisense Fertilitech A/S | 2011-01-11 |
| K050197 | MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045 | Minitube of America, Inc. | 2006-10-06 |
| K041952 | ZIVF-AIRE | Zander Medical Supplies, Inc. | 2005-09-08 |
| K032086 | KRYO ART CONTROLLED RATE FREEZER | Planer Plc | 2004-03-19 |
| K032526 | BINDER CO2 INCUBATOR SERIE CB | Binder GmbH | 2003-08-29 |
| K030525 | CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES | Mid-Atlantic Diagnostics, Inc. | 2003-08-27 |
| K023465 | KENDRO HERACELL 240 INCUBATOR | Kendro Laboratory Products, L.P. | 2003-03-10 |
| K011327 | DB1 EMBRYO FREEZE | Zander Medical Supplies, Inc. | 2002-08-15 |
| K020560 | WORKBENCH BY | Genx Intl., Inc. | 2002-06-19 |
| K021042 | THERMO FORMA, CRYOMED, CONTROLLED RATE FREEZERS; MODELS # 7456, 7457, 7458,7459,7475,7476 | Thermo Forma, Inc. | 2002-05-15 |
| K014160 | PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES) | Cook Urological, Inc. | 2002-02-08 |
| K013703 | SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175M | Sanyo North America Corp. | 2001-12-14 |
| K013401 | K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01 | K-Systems, Kivex Biotec , Ltd. | 2001-12-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 16975737430110 | Metiec | Wuhan Huchuang Union Technology Co., Ltd. | 2024-05-27 |
| 09348265003024 | Geri Connect Server (including software) | GENEA BIOMEDX PTY LTD | 2018-06-19 |
| 09348265003079 | Geri Software Connect and Assess 1.3 | GENEA BIOMEDX PTY LTD | 2018-06-19 |
| 09348265003000 | Geri Embryo Incubator | GENEA BIOMEDX PTY LTD | 2017-12-08 |
| 10850684007010 | Thermo Scientific | Thermo Electron LED GmbH | 2016-09-23 |
| 10850684007003 | Thermo Scientific | Thermo Electron LED GmbH | 2016-09-23 |
| 10815773020226 | Thermo Scientific Forma | THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC | 2016-09-23 |
| 10815773020219 | Thermo Scientific Forma | THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC | 2016-09-23 |
| 10815773020202 | Thermo Scientific Forma | THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC | 2016-09-23 |
| 10815773020196 | Thermo Scientific Forma | THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC | 2016-09-23 |
| 10815773020189 | Thermo Scientific Forma | THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC | 2016-09-23 |
| 10815773020172 | Thermo Scientific Forma | THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC | 2016-09-23 |
| 10815773020127 | Thermo Scientific Forma | THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC | 2016-09-22 |
| 10815773020158 | Thermo Scientific Forma | THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC | 2016-09-22 |
| 10815773020141 | Thermo Scientific Forma | THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC | 2016-09-22 |
| 10815773020134 | Thermo Scientific Forma | THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC | 2016-09-22 |
| 10815773020110 | Thermo Scientific Forma | THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC | 2016-09-22 |
| 10815773020103 | Thermo Scientific Forma | THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC | 2016-09-22 |
| 10815773020097 | Thermo Scientific Forma | THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC | 2016-09-22 |
| 10815773020080 | Thermo Scientific Forma | THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC | 2016-09-22 |
| 10815773020073 | Thermo Scientific Forma | THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC | 2016-09-22 |
| 10815773020066 | Thermo Scientific Forma | THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC | 2016-09-22 |
| 10815773020059 | Thermo Scientific Forma | THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC | 2016-09-22 |
| 10815773020042 | Thermo Scientific Forma | THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC | 2016-09-22 |
| 10815773020035 | Thermo Scientific Forma | THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC | 2016-09-22 |
| 10815773020028 | Thermo Scientific Forma | THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC | 2016-09-22 |
| 10815773020011 | Thermo Scientific Forma | THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC | 2016-09-22 |
| 10815773020004 | Thermo Scientific Forma | THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC | 2016-09-21 |
| 00815965020938 | Coda® | LIFEGLOBAL GROUP, LLC | 2016-09-21 |
| 00815965020945 | Coda® | LIFEGLOBAL GROUP, LLC | 2016-09-21 |