K250129

AViTA Breast Pump

510(k) number
K250129
Device name
AViTA Breast Pump
Applicant
Avita Corporation TW
Product code
HGX — Pump, Breast, Powered
Decision date
2026-06-11
Date received
2025-01-17
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain

Also available from FDA: K250129.pdf

Official FDA record: K250129
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.