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FDA 510(k)

Wallace Dual Lumen Oocyte Recovery System

K-Number: K191291 · 2019-06-12

ApplicantCooperSurgical, Inc.
Decision Date2019-06-12
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 2019-06-12 under approval number K191291. 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 2019-06-12. It is manufactured by CooperSurgical, Inc.. The 510(k) number is K191291.

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

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

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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Related Devices (Code: MQE)

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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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