FDA 510(k)

VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)

Número K: K240523 · 2024-11-15

RequerenteShenzhen Vitavitro Biotech Co., Ltd.

Data da decisão2024-11-15

Código do produtoMQE

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Vitavitro Biotech Co., Ltd.. It received FDA 510(k) clearance on 2024-11-15 under 510(k) number K240523. The device is classified under product code MQE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)?

VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) is a medical device that received FDA 510(k) clearance on 2024-11-15. The listed applicant is Shenzhen Vitavitro Biotech Co., Ltd.. The 510(k) number is K240523.

When did VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) receive FDA 510(k) clearance?

VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) received FDA 510(k) clearance on 2024-11-15, under 510(k) number K240523.

Who is the listed applicant for VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)?

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

What is the FDA product code for VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)?

The FDA product code for VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) is MQE.

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Outros registros que listam Shenzhen Vitavitro Biotech Co., Ltd. como candidato(a)

K240307VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)K212410VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium K200408VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium K1910631-Step Culture Medium

Dispositivos Relacionados (Código: MQE)

K253121Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval NeedleGimbo Medical Technology Shenzhen Co., Ltd.K232163Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration NeedleZhejiang Horizon Medical Technology Co., Ltd.K190590Agulhas de Retirada de Ovário Allwin (Agulha de Retirada de Ovário de Único Lumeno ACE, Agulha de Retirada de Ovário de Duplo Lumeno OVUMPICK, Agulha de Retirada de Ovário de Único Lumeno com Linha de Limpeza ACE-FL, Agulha de Retirada de Ovário Manual de Único Lumeno ACE-M)Allwin Medical Devices, Inc.K191291Wallace Dual Lumen Oocyte Recovery SystemCooperSurgical, Inc.K182959Wallace Dual Lumen Oocyte Recovery SystemCooperSurgical, Inc.K171625Single Lumen Ovum Aspiration NeedlesWillian A. Cook Australia Pty, Ltd.

Fonte oficial

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