510(k) K261083

Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK) by CooperSurgical, Inc. — Product Code MQG

K261083 is an FDA 510(k) premarket notification submitted by CooperSurgical, Inc. for the device "Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK)". The FDA issued a decision of Substantially Equivalent on August 19, 2026. The device falls under product code MQG (Accessory, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6120. CooperSurgical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2026
Date Received
April 1, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6120
Review Panel
OB
Submission Type