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Parker Quality & Compliance

PQC Reg Watch

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510(k) clearance

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

FDA 510(k) source

510(k) number
K261083
Applicant
CooperSurgical, Inc.
Decision date
Aug 19, 2026
Date received
Apr 1, 2026
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
MQG
Device type
Accessory, Assisted Reproduction
Device class
Class II
Regulation
21 CFR 884.6120
Advisory committee
Obstetrics/Gynecology
Statement or summary
Summary
Third party
N
Location
Trumbull, CT, US