FDA 510(k)

Wallace Dual Lumen Oocyte Recovery System

N.º K: K191291 · 2019-06-12

Fecha de decisión2019-06-12

Código de productoMQE

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Otros registros que enlistan a CooperSurgical, Inc. como solicitante

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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.K190590Needles de Recolección de Ovum Allwin (Ace Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, Ace-FL Single Lumen Ovum Pickup Needle con Línea de Limpieza, Ace-M Manual Single Lumen Ovum Pickup Needle)Allwin Medical Devices, Inc.K182959Wallace Dual Lumen Oocyte Recovery SystemCooperSurgical, Inc.K171625Single Lumen Ovum Aspiration NeedlesWillian A. Cook Australia Pty, Ltd.

Fuente oficial

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