Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)— 510(k) K260346

Substantially Equivalent

Polybell (Guangzhou) Limited

FDA 510(k) clearance K260346 for Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706), Substantially Equivalent on 2026-06-12. Applicant: Polybell (Guangzhou) Limited.

Clearance details

Applicant: Polybell (Guangzhou) Limited
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2026-02-03
Decision date: 2026-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code HGX

product code HGX

Injury: 758
Other: 2
Total: 760

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.