FDA 510(k)

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

Numéro K : K241454 · 2025-02-03

DemandeurGuangzhou Hehong Biotech Co., Ltd.

Date de décision2025-02-03

Code produitMQK

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Autres dossiers indiquant Guangzhou Hehong Biotech Co., Ltd. en tant que demandeur

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

Dispositifs connexes (Code : 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

Source officielle

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