K260346
- 510(k) number
- K260346
- Device name
- Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)
- Applicant
- Polybell (Guangzhou) Limited CN
- Product code
- HGX — Pump, Breast, Powered
- Decision date
- 2026-06-12
- Date received
- 2026-02-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
510(k) Summary (official FDA PDF): K260346.pdf
Official FDA record: K260346
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.