FDA 510(k)

SperSort™ Sperm Sorting Chip (IPG02)

Номер K: K241626 · 2025-02-20

Дата решения2025-02-20

Код продуктаMQK

Консультативный комитетOB

РешениеSubstantially Equivalent

Описание устройства

SperSort™ Sperm Sorting Chip (IPG02) is the device name listed in this FDA 510(k) record. The listed applicant is Ipreg Incorporation. It received FDA 510(k) clearance on 2025-02-20 under 510(k) number K241626. 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 SperSort™ Sperm Sorting Chip (IPG02)?

SperSort™ Sperm Sorting Chip (IPG02) is a medical device that received FDA 510(k) clearance on 2025-02-20. The listed applicant is Ipreg Incorporation. The 510(k) number is K241626.

When did SperSort™ Sperm Sorting Chip (IPG02) receive FDA 510(k) clearance?

SperSort™ Sperm Sorting Chip (IPG02) received FDA 510(k) clearance on 2025-02-20, under 510(k) number K241626.

Who is the listed applicant for SperSort™ Sperm Sorting Chip (IPG02)?

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

What is the FDA product code for SperSort™ Sperm Sorting Chip (IPG02)?

The FDA product code for SperSort™ Sperm Sorting Chip (IPG02) 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)

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.K232980SpermAlign Sperm Separation DeviceCytoswim, Ltd.K233177Nest VT Vitrification DeviceCook Incorporated

Официальный источник

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