510(k) K240002
- Device
- G-Vitri? Vitrification Straw
- Applicant
- Gimbo Medical Technology Shenzhen Co., Ltd.
- 510(k) number
- K240002
- Product code
- MQK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-06-14
- Date received
- 2024-01-02
- Regulation
- 884.6160
- Classification name
- Labware, Assisted Reproduction
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Leo Guo
- Address
- 601, Bldg. C5, # 459 Qiaokai Rd., Fenghuang St., Guangming District, Shenzhen City, Guangdong Province Shenzhen CN 518107 518107
FDA Registration Numbers#
- 3002807408
- 3012305175
- 8043396
- 8043792
- 1054657
- 3012853704
- 1058584
- 3014295858
- 1220477
- 3010175289
- 3023235140
- 3003995932
- 3015140190
- 1216677
- 3006405073
- 3006795808
- 3009107689
- 3002497578
- 3009747883
- 1423662
- 3007766601
- 9617744
- 3016927399
- 1221433
- 3016090200
- 3034431159
- 3016838734
- 3033813683
- 3004048494
- 3043639843
- 3015550658
- 3005987240
- 3007738736
- 3004681519
- 2953359
- 3013019894
- 3017247483
- 3014527900
- 9611680
- 3014053517
- 9616005
- 3017896194
- 2022379
- 3003775072
- 1820334
- 3003244268
- 3030681110
- 3015522136
- 1222779
- 2245304
- 3012416874
- 3010781586
- 3008876063
- 3002807090
- 3036495174
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MQK#
| 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 |
| 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 |