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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory, Assisted Reproduction
510(k) Number K261083
Device Name Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK)
Applicant
CooperSurgical, Inc.
95 Corporate Dr.
Trumbull,  CT  06611
Applicant Contact Ewa Paterson
Correspondent
CooperSurgical, Inc.
95 Corporate Dr.
Trumbull,  CT  06611
Correspondent Contact Ewa Paterson
Regulation Number884.6120
Classification Product Code
MQG  
Date Received04/01/2026
Decision Date 08/19/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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