SpermAlign Sperm Separation Device— 510(k) K232980

Substantially Equivalent

Cytoswim, Ltd.

FDA 510(k) clearance K232980 for SpermAlign Sperm Separation Device, Substantially Equivalent on 2024-03-14. Applicant: Cytoswim, Ltd..

Clearance details

Applicant: Cytoswim, Ltd.
Product code: Code MQK
Advisory panel: Obstetrics/Gynecology
Date received: 2023-09-21
Decision date: 2024-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Coventry, GB

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.