K232980
- 510(k) number
- K232980
- Device name
- SpermAlign Sperm Separation Device
- Applicant
- Cytoswim, Ltd. GB
- Product code
- MQK — Labware, Assisted Reproduction
- Decision date
- 2024-03-14
- Date received
- 2023-09-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K232980.pdf
Official FDA record: K232980
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.