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FDA 510(k)

Wallace Dual Lumen Oocyte Recovery System

K-Number: K182959 · 2019-05-10

ApplicantCooperSurgical, Inc.
Decision Date2019-05-10
Product CodeMQE
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Wallace Dual Lumen Oocyte Recovery System is a medical device manufactured by CooperSurgical, Inc.. It received FDA 510(k) clearance on 2019-05-10 under approval number K182959. 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 Wallace Dual Lumen Oocyte Recovery System?

Wallace Dual Lumen Oocyte Recovery System is a medical device that received FDA 510(k) clearance on 2019-05-10. It is manufactured by CooperSurgical, Inc.. The 510(k) number is K182959.

When was Wallace Dual Lumen Oocyte Recovery System approved by the FDA?

Wallace Dual Lumen Oocyte Recovery System received FDA 510(k) clearance on 2019-05-10, under approval number K182959.

What company makes Wallace Dual Lumen Oocyte Recovery System?

Wallace Dual Lumen Oocyte Recovery System is manufactured by CooperSurgical, Inc..

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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Other Devices by CooperSurgical, Inc.

K151845Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula K170560SAGE Vitrification Kit and SAGE Vitrification Warming Kit K180429Advincula Delineator Uterine Manipulator K173731SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031) K191291Wallace Dual Lumen Oocyte Recovery System

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Related Devices (Code: MQE)

K171611Double Lumen Ovum Aspiration NeedlesWilliam A. Cook Australia Pty. , Ltd. K172050Follicle Aspiration Set, Reduced Single LumenVitrolife Sweden AB K162881Kitazato OPU NeedlesKitazato Corporation K161970Follicle Aspiration SetVitrolife Sweden AB K171625Single Lumen Ovum Aspiration NeedlesWillian A. Cook Australia Pty, 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.

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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