FDA 510(k)

Single Lumen Ovum Aspiration Needles

N.º K: K171625 · 2018-01-12

SolicitanteWillian A. Cook Australia Pty, Ltd.

Fecha de decisión2018-01-12

Código de productoMQE

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

Single Lumen Ovum Aspiration Needles is the device name listed in this FDA 510(k) record. The listed applicant is Willian A. Cook Australia Pty, Ltd.. It received FDA 510(k) clearance on 2018-01-12 under 510(k) number K171625. 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 Single Lumen Ovum Aspiration Needles?

Single Lumen Ovum Aspiration Needles is a medical device that received FDA 510(k) clearance on 2018-01-12. The listed applicant is Willian A. Cook Australia Pty, Ltd.. The 510(k) number is K171625.

When did Single Lumen Ovum Aspiration Needles receive FDA 510(k) clearance?

Single Lumen Ovum Aspiration Needles received FDA 510(k) clearance on 2018-01-12, under 510(k) number K171625.

Who is the listed applicant for Single Lumen Ovum Aspiration Needles?

The FDA 510(k) record lists Willian A. Cook Australia Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single Lumen Ovum Aspiration Needles?

The FDA product code for Single Lumen Ovum Aspiration Needles is MQE.

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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.K191291Wallace Dual Lumen Oocyte Recovery SystemCooperSurgical, Inc.K182959Wallace Dual Lumen Oocyte Recovery SystemCooperSurgical, Inc.

Fuente oficial

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