510(k) K232980
- Device
- SpermAlign Sperm Separation Device
- Applicant
- Cytoswim, Ltd.
- 510(k) number
- K232980
- Product code
- MQK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-03-14
- Date received
- 2023-09-21
- 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
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Applicant Contact
- Contact
- Max Meissner
- Address
- Unit 34, The Venture Centre, University Of Warwick Science Park, Coventry GB CV4 7EZ CV4 7EZ
FDA Registration Numbers
- 1423662
- 3012305175
- 3002807090
- 3023235140
- 3004048494
- 2245304
- 3009107689
- 3003775072
- 3030681110
- 3034431159
- 3010781586
- 1221433
- 2022379
- 3006795808
- 3003995932
- 3007766601
- 3014295858
- 3016090200
- 9617744
- 3008876063
- 3015550658
- 3002497578
- 1216677
- 3006405073
- 1058584
- 3017247483
- 3007738736
- 2953359
- 3017896194
- 3016838734
- 3015522136
- 3036495174
- 3043639843
- 3033813683
- 1220477
- 3012416874
- 3004681519
- 1222779
- 3014527900
- 8043792
- 9616005
- 3010175289
- 3009747883
- 1054657
- 1820334
- 3002807408
- 3016927399
- 3014053517
- 3012853704
- 3005987240
- 9611680
- 3015140190
- 3003244268
- 3013019894
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 25070002516204 | SpermAlign | CYTOSWIM LTD | 2025-03-03 |
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| 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 |