Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 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.

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. 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.

Other records listing CooperSurgical, Inc. as applicant

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.

K243799Fetal PillowK250438CooperSurgical Milex® PessariesPMA P160047Device, thermal ablation, endometrialK223064ALLY II Uterine Positioning System™ (UPS)K201086Advincula Delineator Uterine ManipulatorK200038Endosee System

View all 17 devices →

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.K182959Wallace Dual Lumen Oocyte Recovery SystemCooperSurgical, Inc.K171625Single Lumen Ovum Aspiration NeedlesWillian A. Cook Australia Pty, Ltd.

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.

↑