FDA 510(k)

Wallace Dual Lumen Oocyte Recovery System

Número K: K191291 · 2019-06-12

Data da decisão2019-06-12

Código do produtoMQE

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Wallace Dual Lumen Oocyte Recovery System is the device name listed in this FDA 510(k) record. The listed applicant is CooperSurgical, Inc.. It received FDA 510(k) clearance on 2019-06-12 under 510(k) number K191291. 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 Wallace Dual Lumen Oocyte Recovery System?

Wallace Dual Lumen Oocyte Recovery System is a medical device that received FDA 510(k) clearance on 2019-06-12. The listed applicant is CooperSurgical, Inc.. The 510(k) number is K191291.

When did Wallace Dual Lumen Oocyte Recovery System receive FDA 510(k) clearance?

Wallace Dual Lumen Oocyte Recovery System received FDA 510(k) clearance on 2019-06-12, under 510(k) number K191291.

Who is the listed applicant for Wallace Dual Lumen Oocyte Recovery System?

The FDA 510(k) record lists CooperSurgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wallace Dual Lumen Oocyte Recovery System?

The FDA product code for Wallace Dual Lumen Oocyte Recovery System is MQE.

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Outros registros que listam CooperSurgical, Inc. como candidato(a)

K261083Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK)K243799Fetal Pillow K250438CooperSurgical Milex® Pessaries K223064Sistema de Posicionamento Uterino ALLY II™ (UPS)K201086Advincula Delineator Uterine Manipulator K200038Endosee System

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Dispositivos Relacionados (Código: MQE)

K253121Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval NeedleGimbo Medical Technology Shenzhen Co., Ltd.K240523VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)Shenzhen Vitavitro Biotech 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.K182959Wallace Dual Lumen Oocyte Recovery SystemCooperSurgical, Inc.K171625Single Lumen Ovum Aspiration NeedlesWillian A. Cook Australia Pty, Ltd.

Fonte oficial

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