510(k) clearances

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

CooperSurgical, Inc. · Obstetrics/Gynecology

K261083Substantially EquivalentTraditionalMQG
Open FDA's page for this record
Third party flag
N
City
Trumbull
Advisory committee description
Obstetrics/Gynecology
Address 1
95 Corporate Dr.
Statement or summary
Summary
Product code
MQG
Zip code
06611
Applicant
CooperSurgical, Inc.
Decision date
2026-08-19
Decision code
SESE
Country code
US
Device name
Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK)
Advisory committee
OB
Contact
Ewa Paterson
K number
K261083
State
CT
Date received
2026-04-01
Review advisory committee
OB
Postal code
06611
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Accessory, Assisted Reproduction
Medical specialty description
Obstetrics/Gynecology
Regulation number
884.6120
Device class
2
Registration number
3009747883, 3008157119, 3003244268, 1523845, 3005580113, 1221433, 9613662, 3012853704, 1000393132, 1820334, 1222779, 3006405073, 3031594904, 3003775072, 1825146, 3023235140, 3009107689, 3004871219, 3034431159, 9680654, 9610632, 1066270, 3017247483, 1216677
FEI number
3009747883, 3008157119, 3003244268, 1523845, 3005580113, 1221433, 3012853704, 3003751666, 1000393132, 1820334, 3006405073, 3031594904, 3003775072, 1825146, 3023235140, 3009107689, 3000957797, 3034431159, 3002919051, 3017247483, 1216677, 3002808026, 1000120774, 3007530363
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.