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FDA 510(k)

SpermAlign Sperm Separation Device

K-Number: K232980 · 2024-03-14

ApplicantCytoswim, Ltd.
Decision Date2024-03-14
Product CodeMQK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SpermAlign Sperm Separation Device is the device name listed in this FDA 510(k) record. The listed applicant is Cytoswim, Ltd.. It received FDA 510(k) clearance on 2024-03-14 under 510(k) 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. The listed applicant is Cytoswim, Ltd.. The 510(k) number is K232980.

When did SpermAlign Sperm Separation Device receive FDA 510(k) clearance?

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

Who is the listed applicant for SpermAlign Sperm Separation Device?

The FDA 510(k) record lists Cytoswim, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: MQK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241626SperSort™ Sperm Sorting Chip (IPG02)Ipreg IncorporationK241454Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)Guangzhou Hehong Biotech Co., Ltd.K241348SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)Motilitycount ApsK241341cryo-GO Vitrification DeviceFujifilm Irvine ScientificK240002G-Vitri™ Vitrification StrawGimbo Medical Technology Shenzhen Co., Ltd.K233177Nest VT Vitrification DeviceCook Incorporated

Official Source

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

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