FDA 510(k)

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

Número K: K253354 · 2026-02-12

RequerenteGuangzhou Hehong Biotech Co., Ltd.

Data da decisão2026-02-12

Código do produtoMQF

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) 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 2026-02-12 under 510(k) number K253354. The device is classified under product code MQF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)?

Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) is a medical device that received FDA 510(k) clearance on 2026-02-12. The listed applicant is Guangzhou Hehong Biotech Co., Ltd.. The 510(k) number is K253354.

When did Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) receive FDA 510(k) clearance?

Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) received FDA 510(k) clearance on 2026-02-12, under 510(k) number K253354.

Who is the listed applicant for Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)?

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

The FDA product code for Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) is MQF.

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

K241454Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)

Dispositivos Relacionados (Código: MQF)

K243373Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511)Vitrolife Sweden AB K240307VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)Shenzhen Vitavitro Biotech Co., Ltd.K231730FemaSeed Intratubal InseminationFemasys, Inc.K220010Daylily Single Use Sterile Embryo Transfer CatheterShanghai Horizon Medical Technology Co., Ltd.K200248Cateteres de Transferência de Embrião Allwin (ETC), Estiletes e Obturadores Macios Allwin ETCAllwin Medical Devices, Inc.K192540Kitazato ET CathetersKitazato Corporation

Fonte oficial

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