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FDA 510(k)

Double Lumen Ovum Aspiration Needles

K-Number: K171611 · 2017-12-15

ApplicantWilliam A. Cook Australia Pty. , Ltd.
Decision Date2017-12-15
Product CodeMQE
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Double Lumen Ovum Aspiration Needles is the device name listed in this FDA 510(k) record. The listed applicant is William A. Cook Australia Pty. , Ltd.. It received FDA 510(k) clearance on 2017-12-15 under 510(k) number K171611. The device is classified under product code MQE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Double Lumen Ovum Aspiration Needles?

Double Lumen Ovum Aspiration Needles is a medical device that received FDA 510(k) clearance on 2017-12-15. The listed applicant is William A. Cook Australia Pty. , Ltd.. The 510(k) number is K171611.

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

Double Lumen Ovum Aspiration Needles received FDA 510(k) clearance on 2017-12-15, under 510(k) number K171611.

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

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

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

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

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Related Devices (Code: MQE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.K190590Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, 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.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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