K253510
- 510(k) number
- K253510
- Device name
- Freestyle Mini Hands-free
- Applicant
- Medela, LLC IL · US
- Product code
- HGX — Pump, Breast, Powered
- Decision date
- 2026-04-10
- Date received
- 2025-11-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K253510.pdf
Official FDA record: K253510
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.