FDA 510(k)

SpermAlign Sperm Separation Device

K-Number: K232980 · 2024-03-14

Decision Date2024-03-14

Product CodeMQK

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

SpermAlign Sperm Separation Device is a medical device manufactured by Cytoswim, Ltd.. It received FDA 510(k) clearance on 2024-03-14 under approval number K232980. The device is classified under product code MQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SpermAlign Sperm Separation Device?

SpermAlign Sperm Separation Device is a medical device that received FDA 510(k) clearance on 2024-03-14. It is manufactured by Cytoswim, Ltd.. The 510(k) number is K232980.

When was SpermAlign Sperm Separation Device approved by the FDA?

SpermAlign Sperm Separation Device received FDA 510(k) clearance on 2024-03-14, under approval number K232980.

What company makes SpermAlign Sperm Separation Device?

SpermAlign Sperm Separation Device is manufactured by Cytoswim, Ltd..

What is the FDA product code for SpermAlign Sperm Separation Device?

The FDA product code for SpermAlign Sperm Separation Device is MQK.

Related Clinical Trials

NCT07605182 Effectiveness of Live Motile Sperm Sorting Device on IVF Outcomes in Advanced Paternal Age NOT_YET_RECRUITING NCT06238570 Validation of Donor Oocytes Semi-automated Vitrification RECRUITING NCT04907071 Intravascular Ultrasound for the Evaluation of Malperfusion Syndrome in the Setting of Acute Aortic Dissection COMPLETED

Related Devices (Code: MQK)

K162051CryotecReprolife, Inc. K153027Cryotop USKitazato Biopharma Co., Ltd. K162640iVitri EZReprobitech Corp. K162833VitriGuardOrigio A/S K181469Cryotop®US-flash and Cryotop®US-scoopKitazato Corporation K180740VitriGuardOrigio A/S

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.