FDA 510(k)

SpermAlign Sperm Separation Device

Номер K: K232980 · 2024-03-14

Дата решения2024-03-14

Код продуктаMQK

Консультативный комитетOB

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: MQK)

K241626SperSort™ Sperm Sorting Chip (IPG02)Ipreg Incorporation K241454Minvitro® 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 Aps K241341cryo-GO Vitrification DeviceFujifilm Irvine Scientific K240002G-Vitri™ Vitrification StrawGimbo Medical Technology Shenzhen Co., Ltd.K233177Nest VT Vitrification DeviceCook Incorporated

Официальный источник

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