FDA 510(k)

Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)

N.º K: K241454 · 2025-02-03

SolicitanteGuangzhou Hehong Biotech Co., Ltd.

Fecha de decisión2025-02-03

Código de productoMQK

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Hehong Biotech Co., Ltd.. It received FDA 510(k) clearance on 2025-02-03 under 510(k) number K241454. The device is classified under product code MQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)?

Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) is a medical device that received FDA 510(k) clearance on 2025-02-03. The listed applicant is Guangzhou Hehong Biotech Co., Ltd.. The 510(k) number is K241454.

When did Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) receive FDA 510(k) clearance?

Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) received FDA 510(k) clearance on 2025-02-03, under 510(k) number K241454.

Who is the listed applicant for Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)?

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

What is the FDA product code for Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)?

The FDA product code for Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) is MQK.

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Otros registros que enlistan a Guangzhou Hehong Biotech Co., Ltd. como solicitante

K253354Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)

Dispositivos relacionados (Código: MQK)

K241626SperSort™ Sperm Sorting Chip (IPG02)Ipreg Incorporation 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

Fuente oficial

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