MQK — Labware, Assisted Reproduction Class II
FDA Device Classification
Classification Details
- Product Code
- MQK
- Device Class
- Class II
- Regulation Number
- 884.6160
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K241626 | ipreg incorporation | SperSort Sperm Sorting Chip (IPG02) | February 20, 2025 |
| K241454 | guangzhou hehong biotech co | Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT | February 3, 2025 |
| K241348 | motilitycount aps | SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) | January 31, 2025 |
| K241341 | fujifilm irvine scientific | cryo-GO Vitrification Device | September 26, 2024 |
| K240002 | gimbo medical technology shenzhen co | G-Vitri Vitrification Straw | June 14, 2024 |
| K232980 | cytoswim | SpermAlign Sperm Separation Device | March 14, 2024 |
| K233177 | cook incorporated | Nest VT Vitrification Device | March 8, 2024 |
| K221810 | bonraybio co | LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device | October 31, 2022 |
| K213869 | vitrolife | EmbryoSlide+ ic8 dish | March 11, 2022 |
| K203626 | allwin medical devices | SureStrip Vitrification Straw, SureLock Vitrification Straw | June 4, 2021 |
| K201213 | hertart aps | Pasteur Pipette 3mL, Pasteur Pipette 1mL | December 16, 2020 |
| K200815 | origio | VitriGuard | June 25, 2020 |
| K181461 | vitrolife sweden | Rapid-i Kit | January 4, 2019 |
| K181469 | kitazato corporation | Cryotop®US-flash and Cryotop®US-scoop | November 9, 2018 |
| K180740 | origio | VitriGuard | May 4, 2018 |
| K173075 | dxnow | ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, | March 8, 2018 |
| K172751 | reprobitech | iVitri Straw | February 9, 2018 |
| K162640 | reprobitech | iVitri EZ | June 30, 2017 |
| K162833 | origio | VitriGuard | February 16, 2017 |
| K162051 | reprolife | Cryotec | December 14, 2016 |