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The Tracker / August 2026 / K261083

510(k) cleared

Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK)

CooperSurgical, Inc. · Aug 19, 2026 · K261083

FDA cleared the Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK) from CooperSurgical, Inc. on Aug 19, 2026 under K261083, a traditional 510(k). The device falls under product code MQG, Accessory, Assisted Reproduction, regulated at 21 CFR 884.6120 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Apr 1, 2026. The decision came 140 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for CooperSurgical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261083?

K261083 is the FDA 510(k) for Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK), submitted by CooperSurgical, Inc.. FDA's decision date was Aug 19, 2026, under product code MQG (Accessory, Assisted Reproduction).

Who makes the Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK)?

CooperSurgical, Inc., based in Trumbull, CT, is the applicant of record for K261083.

How long did the K261083 review take?

FDA received the submission on Apr 1, 2026 and issued its decision on Aug 19, 2026, 140 days later.

← All decisions in August 2026