K261083
- 510(k) number
- K261083
- Device name
- Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK)
- Applicant
- CooperSurgical, Inc. CT · US
- Product code
- MQG — Accessory, Assisted Reproduction
- Decision date
- 2026-08-19
- Date received
- 2026-04-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K261083.pdf
Official FDA record: K261083
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.