FDA 510(k)

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

Número K: K241454 · 2025-02-03

RequerenteGuangzhou Hehong Biotech Co., Ltd.

Data da decisão2025-02-03

Código do produtoMQK

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Guangzhou Hehong Biotech Co., Ltd. como candidato(a)

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

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.